A Retrospective Analysis of Post-Stroke Rehabilitation with Real World Use of Brain- Computer Interface

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Prasad, Allison L. Goldring, Nikhita J. Perry, Lee A. Fleisher, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6305433/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Jan, 2026 Read the published version in Journal of NeuroEngineering and Rehabilitation → Version 1 posted 11 You are reading this latest preprint version Abstract The IpsiHand™ System is an FDA-authorized, non-invasive therapy for chronic stroke-induced motor impairment that leverages a brain-computer interface (BCI) to actuate ipsilateral intent-to-move signals. This study aimed to use real-world evidence to determine device effectiveness when used by stroke survivors at least 6 months after stroke onset. A quality assurance database was retrospectively reviewed for chronic stroke survivors who were prescribed IpsiHand™ and opted to receive regular Upper Extremity Fugl-Meyer Assessments (UEFM) as part of routine clinical care. Early responders, who achieved the minimal clinically important difference (MCID) of 5.25 points from the baseline UEFM score by 6 weeks of use, showed statistically significant continuous improvement in upper extremity function over time as compared to early non-responders, who did not surpass the MCID by 12 weeks. Additionally, early responders showed greater UEFM score improvement compared to intermediate responders, defined as those who did not surpass the MCID until 12 weeks. Altogether, 70% (39/56) of the analysis population achieved the UEFM MCID using all reported UEFM scores out through 55 weeks. The results suggest that IpsiHand™ therapy should be utilized for a minimum of 12 weeks to determine if a chronic stroke survivor can derive significant clinical benefit, with evidence of individuals achieving clinically meaningful response after longer periods of therapy. The continued collection of real-world evidence is crucial to further explore long-term functional improvement enabled by IpsiHand™ and establish predictive characteristics of responders. Chronic Stroke Rehabilitation Brain-Computer Interface IpsiHand Upper Extremity Motor Function Figures Figure 1 Introduction Stroke is a leading cause of death and disability in the United States. 1 , 2 More than 795,000 people have a stroke each year, 1 culminating in 7.8 million Americans (3.1% of U.S. adult population) who were identified as stroke survivors by the CDC National Center for Health Statistics in 2018. 2 The number of strokes was predicted to double from 2010 to 2050, with the majority of the predicted increase attributable to those over 75 years of age. 3 Paresis is the most common stroke-induced motor impairment and presents clinically as a weakness resulting in slower, less accurate, and less efficient movements. 4 The post-stroke recovery process is logarithmic and time-dependent: the most significant functional improvements occur in the first few weeks after onset and approach asymptotic levels after 3 months. 5 , 6 Survivors enter the chronic stroke stage at 6 months post-stroke, which is characterized by limited potential for biological spontaneous recovery; functional impairments present at the 6-month mark often become permanent disabilities in the “chronic stroke” phase. 7 , 8 Towards tracking post-stroke motor recovery, the change in Upper Extremity Fugl-Meyer Assessment (UEFM) scores from baseline is a validated and widely used measure of upper extremity motor function. 9 , 10 The UEFM was constructed to be sensitive to change in motor function, designed to spread 66 points over 33 tasks. 10 The UEFM has established excellent intra-rater and interrater reliability, excellent validity, and good responsiveness using Spearman’s correlation. 10 This measurement has been used to infer motor performance in chronic poststroke individuals, an important aspect of the stroke survivor population that is historically understudied. 11 The Neurolutions IpsiHand™ Upper Extremity Rehabilitation System (IpsiHand™) was authorized by the FDA in 2021 as a chronic stroke therapy to facilitate muscle re-education and maintain or increase range of motion in the upper extremity for adult patients ≥ 6 months post-stroke. 12 IpsiHand™ leverages a novel, non-invasive, form of brain-computer interface (BCI) technology to detect electrical signals from the uninjured hemisphere of the brain corresponding to intent-to-move brain activity, which then controls the movement of a distal wearable exoskeleton worn around the affected hand and wrist. The repetition of this process promotes Hebbian learning, enabling neural circuit reorganization and restoration of motor function. 13 In the pivotal clinical studies supporting FDA authorization, all 40 chronic stroke survivors who used IpsiHand™ over a 12-week period demonstrated motor function improvement as measured by an increase in UEFM scores from baseline. 12 To better understand the clinical utility of IpsiHand™ in real-world use, a retrospective review of a quality assurance database was conducted for people with stroke who were prescribed IpsiHand™ and opted to undergo regular UEFM assessments as part of routine clinical care. Methods This retrospective study analyzed de-identified patient data previously collected by the manufacturer’s team over a two-year period for quality assurance purposes. De-identified data included the date of first device use, the date of baseline UEFM score collection, baseline UEFM scores, and any subsequent UEFM scores with their respective collection dates. Demographic information was aggregated in Table 1 following the analysis. Inclusion criteria included age between 18 and 85 years, stroke sustained at least six months prior to initial IpsiHand™ use, prescription of IpsiHand™ in accordance with its FDA-authorized indication, and exhibition of hemiparesis or hemiplegia as measured by cognitive function, language, motor function, and visual attention screening tests. Exclusion criteria included absence of a baseline UEFM score measurement and measurement of baseline UEFM score occurring more than one week after initiating device use. The primary data for this retrospective study was UEFM score measurements that were virtually assessed at approximate 6-week intervals for consenting subjects as part of routine stroke rehabilitation care. Given the irregularity of UEFM measurements in real-world use, only assessments conducted within ± 1 week of the 6-, 12-, 18-, 24-week measurements were included in the analysis, with larger ranges of weeks used for the extended time points beyond 29 weeks. To mitigate missing data bias in the dataset, only entries with sufficient data to categorize the chronic stroke survivor as early responders, intermediate responders, and non-responders were included in the analysis. A ≥ 5.25 point change in the UEFM score was chosen as the threshold for clinically meaningful improvement based on existing literature and expert consensus. 14 Early responders were classified as those who achieved a ≥ 5.25-point increase in UEFM score at the 6-week measurement. Intermediate responders were classified as those who did not achieve MCID at 6 weeks but surpassed the MCID at 12 weeks. This classification required that both the 6-week and 12-week UEFM scores were measured for each IpsiHand™ user. As such, 3 subjects with 12-week UEFM scores above MCID and missing 6-week scores were not included in the analysis, given the ambiguity in classification as an intermediate responder or early responder. Finally, early non-responders were classified as those who did not achieve a ≥ 5.25-point increase in UEFM score at the 12-week measurements. 19 subjects with only 6-week UEFM scores below MCID and missing 12-week scores were not included in the analysis, given the ambiguity in classification as an early non-responder or intermediate responder. After these exclusions, a total of 56 subjects were included in the analysis. Data analysis was conducted using Microsoft Excel and RStudio. Comparisons of the primary outcome were performed using Kruskal-Wallis tests. Post hoc analyses were conducted using Dunn’s tests with Bonferroni correction. Statistical significance was defined as a p-value of < 0.05. Results Table 1: Patient Demographics Table TOTAL Early responders Early non-responders Intermediate responders Age (at Baseline Assessment) mean (SD) 61.7 (12.2) 57.6 (12.7) 65.9 (9.6) 66.0 (13.4) median (IQ1, IQ3) 63.9 (53.6, 70.1) 59.7 (46.0, 66.8) 65.9 (58.0, 73.9) 68.5 (54.6, 76.0) range 32.8-82.7 32.8-77.1 50.7- 82.7 49.2- 81.2 ≥80 years of age, n (%) 3 (5.4%) 0 (0.0%) 2 (10.0%) 1 (14.3%) 65-79 years of age, n (%) 18 (32.1%) 8 (27.6%) 8 (40.0%) 2 (28.6%) 50-64 years of age, n (%) 21 (37.5%) 10 (34.5%) 9 (45.0%) 2 (28.6%) 30-49 years of age, n (%) 9 (16.1%) 8 (27.6%) 0 (0.0%) 1 (14.3%) 18-29 years of age, n (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) missing, n (%) 5 (8.9%) 3 (10.3%) 1 (5.0%) 1 (14.3%) Clinical Characteristics Side of Lesion left, n (%) 35 (62.5%) 19 (65.5%) 12 (60.0%) 4 (57.1%) right, n (%) 20 (35.7%) 10 (34.5%) 8 (40.0%) 2 (28.6%) unknown, n (%) 1 (1.8%) 0 (0.0%) 0 (0.0%) 1 (14.3%) Baseline UEFM Score mean (SD) 18.9 (12.8) 18.7 (11.2) 18.9 (14.7) 20.3 (14.8) median (IQ1, IQ3) 16.0 (9.8, 25.0) 18.0 (10.0, 22.0) 14.5 (9.0, 25.5) 17.0 (9.5, 25.5) range (3-61) (4-46) (3-61) (8-47) mild (UEFM ≥ 43), n (%) 5 (8.9%) 2 (7.4%) 2 (10.0%) 1 (14.3%) moderate (UEFM = 29-42), n (%) 5 (8.9%) 3 (11.1%) 1 (5.0) 1 (14.3%) severe (UEFM = 0-28), n (%) 46 (82.1%) 24 (88.9%) 17 (85.0%) 5 (71.4%) Table 2: Achievement of MCID over time The number and percentage of the 56 chronic stroke survivors who achieve or do not achieve the UEFM MCID of 5.25 points score change from baseline at the 6-week measurement and 12-week measurement, including those with missing data for either assessment week that did not create ambiguity in response classification. 6 weeks 12 weeks n % UEFM available at both 6 and 12 weeks 30 53% >MCID >MCID 12 40% >MCID <MCID 0 0% MCID 7 23% <MCID MCID N/A 17 100% UEFM available at 12 weeks only 9 16% N/A MCID within 12 weeks 36 64% Subjects >MCID post 12 weeks 3 5% Subjects not >MCID TOTAL 17 30% Subjects >MCID TOTAL 39 70% First, we sought to understand how early indication of a clinically significant UEFM score improvement may influence the durability of the score over time. Chronic stroke survivors using IpsiHand™ were categorized according to achievement of MCID at 6 or 12 weeks, and the reported changes in UEFM score from baseline for each group were averaged over time ( Figure 1 ). To mitigate missing data biases, only subjects who could be assigned to three distinct categories were included in the analysis: early responder, intermediate responders, and early non-responders. Early responders (n=29)—those who surpassed the UEFM MCID of at least 5.25 points change from baseline at the 6-week mark—showed statistically significant improvement in upper extremity function on average over time compared to the early non-responders (n=20)—those who fell short of the MCID by 6 or 12 weeks (Week 18, p=0.005; Week 24, p=0.016). Early responders showed numerically greater improvement in UEFM scores at 18 and 24 weeks on average as compared to the intermediate responders (n=7) —those who did not surpass the MCID at 6 weeks but did at 12 weeks ( Figure 1 ). A total of 64% (36/56) of the analyzed population derived meaningful clinical benefit by 12 weeks. Analysis of longer durations of use beyond 12 weeks revealed the potential for functional improvement over time. In the early non-responder group, 35% (7/20) reported long-term UEFM scores between weeks 29 and 55. Of these subjects, 43% (3/7) revealed delayed achievement of the MCID ( Table 2 ). Given that the remaining 65% (13/20) of early non-responders have not reported long-term UEFM scores beyond 29 weeks, the probability and time required for early non-responders to surpass the MCID threshold remains an open question. Next, we determined the overall IpsiHand™ response rate over the course of time. Altogether, 70% ((29+7+3)/56) of the analysis population achieved the UEFM MCID using all reported UEFM scores out through 55 weeks ( Table 2 ). Of the chronic stroke survivors with reported 6-week UEFM scores, 29/56 (52%) were early responders, surpassing the MCID by 6 weeks ( Table 2 ). We note that all early responders with reported 12-week UEFM scores continued to surpass the MCID threshold after the 6-week assessment. An additional 39% (7/18) of subjects surpassed the MCID at 12 weeks despite failing to do so at 6 weeks, representing intermediate responders. To more clearly contextualize the UEFM score change, we determined how many chronic stroke survivors transitioned between the following poststroke impairment categorizations defined by Woytowicz et. al .: severe (0-28), moderate (29-42), and mild (43-66). The baseline scores of the 56 chronic stroke survivors ranged from 3 to 61, with an average of 18.9 and a median of 16 (IQ1: 9.8, IQ3: 25) ( Table 1 ). Most of the patient population in this study, 46/56 (82%), was classified as having severe poststroke motor impairments at baseline prior to initiating IpsiHand™ therapy. For these chronic stroke survivors initiating IpsiHand™ therapy with severe poststroke motor impairments, 15/46 (33%) transitioned to lower severity impairments over the course of therapy and 29/46 (63%) surpassing MCID by 12 weeks ( Table 3 ). Of the 56 chronic stroke survivors with UEFM scores variably reported over 24 weeks, 10/46 (22%) reported sufficient data to indicate a transition from severe to moderate, 5/46 (11%) from severe to mild, and 1/5 (20%) from moderate to mild ( Table 3 ). All of the remaining 5/56 chronic stroke survivors classified as having mild motor impairments at baseline demonstrated increase in UEFM score, with 3/5 (60%) reporting sufficient data to indicate that the MCID threshold was surpassed between 5-13 weeks. Vagus Nerve Stimulation (VNS) has been shown to be effective in chronic stroke upper-extremity rehabilitation, however, the inclusion criteria in the pivotal clinical trial for Vivistim Paired VNS System specify a baseline UEFM of >20. 15 In this study, 36/56 (64%) of subjects started with a baseline UEFM score <20. We observed that 50% (18/36) of these subjects crossed the 20-point UEFM score threshold with IpsiHand™ usage. Table 3: Reduction in post-stroke upper extremity impairment The proportion of the 56 chronic stroke survivors with baseline UEFM measurements characterized as severe, moderate, or mild post-stroke motor impairments per Woytowicz et. al.: severe (0 -28), moderate (29 -42), and mild (43 -66) . 16 cases where the available UEFM data over the 55-week period indicates an individual’s transition between categories are denoted. End Point UEFM Classification Total Initial UEFM Classification Severe Moderate Mild Baseline Severe 31 10 5 46/56 (82%) Baseline Moderate 4 1 5/56 (9%) Baseline Mild 5 5/56 (9%) Discussion Use of IpsiHand™ as part of real-world therapy in this study was associated with improvement in upper extremity function for 70% (39/56) of chronic stroke survivors with an average UEFM baseline score of 18.9. We observed several patterns of response, including 52% (29/56) of chronic stroke survivors exhibiting an early response within the first 6 weeks of use. Among IpsiHand™ users who do not demonstrate a clinically meaningful response at 6 weeks, 39% (7/18) surpassed the MCID at the 12 weeks. For the early non-responders who did not achieve a clinically meaningful response by 6 or 12 weeks, the available reported data up to 55 weeks reveals the potential to achieve MCID after an extended period of therapy. The lack of regularly measured and reported UEFM scores, inherent to real-world evidence studies, yielded missing data inputs, which led to exclusion of IpsiHand™ users from the analysis group given no data imputation was performed. Future clinical studies with more rigorous UEFM collection at each timepoint are required for more comprehensive analysis. The findings of this study are consistent with the clinical trials of IpsiHand™ for FDA authorization for a similar patient population with less severe poststroke motor impairments on average (mean baseline UEFM score of 26.9 points, median of 24.5 points). 16 , 17 In the 12-week trial with IpsiHand™, used for 1 hour/day, 5 days/week, and over the course of 12 weeks, 18/26 (69%) subjects surpassed the MCID, and the mean increase in UEFM score was 8.1 points. 13 In this real-world study, where patient adherence to recommended treatment guidelines was not enforced, 21/42 (50%) subjects with reported 12-week scores surpassed the MCID, and the mean increase in reported 12-week UEFM scores was 6.87 points. Including the subjects who are missing 12-week UEFM scores but whose 6-week UEFM scores surpass MCID, a total of 64% (39/56) of subjects surpassed MCID by 12 weeks. The results of this study suggest that IpsiHand™ should be utilized for a minimum of 12 weeks to determine if a chronic stroke survivor can derive significant clinical benefit and if early responders continue to improve, with evidence of clinically meaningful responses achieved after longer (> 12 week) periods of therapy. We propose to conduct future studies to identify predictors of patient response to IpsiHand™ therapy, including individualized estimates of the potential extent of motor recovery possible and expected time to achieve MCID. The continued collection of this real-world evidence is crucial to further explore long-term functional improvement enabled by IpsiHand™ for chronic stroke survivors. Limitations The primary limitation of this study is the retrospective analysis of data, as it was collected from individuals who participated in a quality assurance program to provide feedback to users. Given the goal of assessing real-world use of the device, we anticipate variability in IpsiHand™ usage patterns, specifically in the number of sessions, session durations, and repetitions completed per session, which may impact the extent and time required to achieve meaningful clinical benefit. Additionally, a limitation of the UEFM outcome measure is the potential for study participants to achieve the MCID not through motor recovery of the affected limb, but rather through the development of compensatory motor patterns, such as increasing bilateral upper extremity movements or increasing unilateral movements of the non-paretic upper extremity. Conclusion This retrospective real-world evidence study demonstrates that chronic stroke survivors (6 months post-stroke), including those classified as having severe motor impairments at baseline, can achieve clinically meaningful functional improvement through use of IpsiHand™. For chronic stroke survivors who derive clinical benefit by 6 weeks, UEFM scores were observed to increase further over 12 and 24 weeks. Even among those who did not exhibit MCID by 6 weeks, a significant portion were observed to surpass this threshold by 12 weeks and sustain the improvement over time. For chronic stroke survivors who did not derive meaningful clinical benefit at 12 weeks, limited data suggests that the possibility of future recovery remains open. Abbreviations BCI: Brain-Computer Interface MCID: Minimal Clinically Important Difference UEFM: Upper Extremity Fugl-Meyer Assessments VNS: Vagus Nerve Stimulation Declarations Ethics Approval and Consent to Participate All participants provided written/verbal consent to participation, and the study was determined to be exempt from Institutional Review Board oversight by the WCG IRB. Consent for Publication Not applicable. Data Availability The data generated and analyzed in this study are not publicly available to protect patient information but are available from the corresponding author on reasonable request. Conflict of Interest/Competing Interests N.K.P., L.A.F., A.L.G. and N.J.P. are employees of Rubrum Advising, which is under contract with Neurolutions, Inc., and L.P., L.S., and S.J.W. are employees of Neurolutions, Inc. Funding This work was funded by Neurolutions, Inc. Acknowledgements Authors would like to thank the study participants for their contributions. Author Contribution S.J.W, L.A.F., L.S., and L.P. led the conception and design of the work. N.K.P. and N.J.P. led the analysis of the data. S.J.W., L.A.F, L.S., and L.P. contributed to the interpretation of the data. A.L.G. drafted the work and substantial revisions were provided by N.K.P., L.A.F., and S.J.W. References How many people are affected by/at risk for stroke? 2024. https://www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk Villarroel M, Blackwell D, Jen A. Tables of Summary Health Statistics for U.S. Adults: 2018 National Health Interview Survey . 2019. http://www.cdc.gov/nchs/nhis/SHS/tables.htm. Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation . 2023;147(8):e93-e621. doi:doi:10.1161/CIR.0000000000001123 Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther . Apr-Jun 2013;26(2):104-14;quiz 115. doi:10.1016/j.jht.2012.06.005 Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke . 2003;34(9):2181-2186. Nishimura Y, Onoe H, Morichika Y, Perfiliev S, Tsukada H, Isa T. Time-dependent central compensatory mechanisms of finger dexterity after spinal cord injury. Science . 2007;318(5853):1150-1155. Bernhardt J, Hayward KS, Kwakkel G, et al. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke . Jul 2017;12(5):444-450. doi:10.1177/1747493017711816 H N, HS J, HO R, TS O. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study - PubMed. Archives of physical medicine and rehabilitation . 1994 Apr;75(4)doi:10.1016/0003-9993(94)90161-9 Fugl-Meyer AR, Jääskö L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med . 1975;7(1):13-31. Gladstone DJ, Danells CJ, Black SE. The Fugl-Meyer Assessment of Motor Recovery after Stroke: A Critical Review of Its Measurement Properties. Neurorehabilitation and Neural Repair . 2002;16(3):232-240. doi:10.1177/154596802401105171 Rech KD, Salazar AP, Marchese RR, Schifino G, Cimolin V, Pagnussat AS. Fugl-Meyer Assessment Scores Are Related With Kinematic Measures in People with Chronic Hemiparesis after Stroke. Journal of Stroke and Cerebrovascular Diseases . 2020/01/01/ 2020;29(1):104463. doi:https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.104463 US Food and Drug Administration. Neurolutions IpsiHand: De Novo Classification Approval Letter. 2020. Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. Neurorehabil Neural Repair . Sep 30 2024:15459683241287731. doi:10.1177/15459683241287731 Page SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Phys Ther . Jun 2012;92(6):791-8. doi:10.2522/ptj.20110009 PMA P210007: FDA Summary of Safety and Effectiveness Data (2021). Bundy DT, Souders L, Baranyai K, et al. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke . Jul 2017;48(7):1908-1915. doi:10.1161/strokeaha.116.016304 Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. Neurorehabil Neural Repair . Jan 2025;39(1):74-86. doi:10.1177/15459683241287731 Additional Declarations Competing interest reported. N.K.P., L.A.F., A.L.G. and N.J.P. are employees of Rubrum Advising, which is under contract with Neurolutions, Inc., and L.P., L.S., and S.J.W. are employees of Neurolutions, Inc. Cite Share Download PDF Status: Published Journal Publication published 21 Jan, 2026 Read the published version in Journal of NeuroEngineering and Rehabilitation → Version 1 posted Editorial decision: Revision requested 30 Jun, 2025 Reviews received at journal 29 Jun, 2025 Reviews received at journal 25 Jun, 2025 Reviews received at journal 11 Jun, 2025 Reviewers agreed at journal 11 Jun, 2025 Reviewers agreed at journal 09 Jun, 2025 Reviewers agreed at journal 09 Jun, 2025 Reviewers invited by journal 09 Jun, 2025 Editor assigned by journal 25 Mar, 2025 Submission checks completed at journal 25 Mar, 2025 First submitted to journal 25 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6305433","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Short Report","associatedPublications":[],"authors":[{"id":434462183,"identity":"e9e1ae35-dc1d-4c17-b40b-3a772460d2fd","order_by":0,"name":"Neha K. 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Wilk","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2klEQVRIiWNgGAWjYHACNoYPYJq5gYHBgCgdzGyMM8AMxgaGA8RqYeaBayFGg3x7/7HHtjtsEre3N7ZJfyiwyZNvYH746AYeLQZnDrMb555JS5xz5mCbxAGDtGKDA2zGxjn4tEgks0nnth1OnCGRCNJyOHEDAw+bND4t8vMfs0lbtv1HaJnfQEALww1mNmnGtgMILQ0HCGgxOJNsJtnblmw8g+dgs8UZg7TEDYcJ+EW+/eAziZ9tdrIz2JsP3qj4Y5M4v7354WO8DsMEzKQpHwWjYBSMglGABQAAEB1LdYsiVdEAAAAASUVORK5CYII=","orcid":"","institution":"Neurolutions, Inc.","correspondingAuthor":true,"prefix":"","firstName":"Seth","middleName":"J.","lastName":"Wilk","suffix":""}],"badges":[],"createdAt":"2025-03-25 15:53:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6305433/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6305433/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12984-026-01880-4","type":"published","date":"2026-01-21T15:58:12+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":79730373,"identity":"e60254c1-42d3-4df7-89fb-12fc9d90c89f","added_by":"auto","created_at":"2025-04-02 05:33:43","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":378983,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eAverage change in UEFM score from baseline was calculated for 56 chronic stroke survivors, who were categorized as follows: 1) Early responders (purple): chronic stroke survivors with 6-week UEFM scores that are 5.25 points change from baseline; 2) intermediate responders (blue): chronic stroke survivors with \u0026lt;5.25 point change in 6-week UEFM scores AND \u0026gt; 5.25 point change in 12-week UEFM scores from baseline; 3) delayed-responders (brown): chronic stroke survivors with \u0026lt; 5.25 points change from baseline in 6-week UEFM scores AND 12-week UEFM scores. The sample size corresponding to the average UEFM change measured during each time range is notated as “n=”. Dashed lines are used between data points with sample size of n \u0026lt; 3. Statistical significance per post-hoc Dunn test was observed between the early responder and early non-responder groups at the 18-week (p=0.005) and 24-week (p=0.016) time points.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6305433/v1/fd0db464657fe8d418689a72.jpeg"},{"id":101151747,"identity":"14cb3239-9e1c-4338-87a8-6c8a3ac00666","added_by":"auto","created_at":"2026-01-26 16:04:26","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1160268,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6305433/v1/d7f3ff2b-1510-49c8-87ad-33ff053125aa.pdf"}],"financialInterests":"Competing interest reported. N.K.P., L.A.F., A.L.G. and N.J.P. are employees of Rubrum Advising, which is under contract with Neurolutions, Inc., and L.P., L.S., and S.J.W. are employees of Neurolutions, Inc.","formattedTitle":"A Retrospective Analysis of Post-Stroke Rehabilitation with Real World Use of Brain- Computer Interface","fulltext":[{"header":"Introduction","content":"\u003cp\u003eStroke is a leading cause of death and disability in the United States.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e More than 795,000 people have a stroke each year,\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e culminating in 7.8\u0026nbsp;million Americans (3.1% of U.S. adult population) who were identified as stroke survivors by the CDC National Center for Health Statistics in 2018.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e The number of strokes was predicted to double from 2010 to 2050, with the majority of the predicted increase attributable to those over 75 years of age.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eParesis is the most common stroke-induced motor impairment and presents clinically as a weakness resulting in slower, less accurate, and less efficient movements.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e The post-stroke recovery process is logarithmic and time-dependent: the most significant functional improvements occur in the first few weeks after onset and approach asymptotic levels after 3 months.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e Survivors enter the chronic stroke stage at 6 months post-stroke, which is characterized by limited potential for biological spontaneous recovery; functional impairments present at the 6-month mark often become permanent disabilities in the \u0026ldquo;chronic stroke\u0026rdquo; phase.\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eTowards tracking post-stroke motor recovery, the change in Upper Extremity Fugl-Meyer Assessment (UEFM) scores from baseline is a validated and widely used measure of upper extremity motor function.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e The UEFM was constructed to be sensitive to change in motor function, designed to spread 66 points over 33 tasks.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e The UEFM has established excellent intra-rater and interrater reliability, excellent validity, and good responsiveness using Spearman\u0026rsquo;s correlation.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e This measurement has been used to infer motor performance in chronic poststroke individuals, an important aspect of the stroke survivor population that is historically understudied.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe Neurolutions IpsiHand\u0026trade; Upper Extremity Rehabilitation System (IpsiHand\u0026trade;) was authorized by the FDA in 2021 as a chronic stroke therapy to facilitate muscle re-education and maintain or increase range of motion in the upper extremity for adult patients\u0026thinsp;\u0026ge;\u0026thinsp;6 months post-stroke.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e IpsiHand\u0026trade; leverages a novel, non-invasive, form of brain-computer interface (BCI) technology to detect electrical signals from the uninjured hemisphere of the brain corresponding to intent-to-move brain activity, which then controls the movement of a distal wearable exoskeleton worn around the affected hand and wrist. The repetition of this process promotes Hebbian learning, enabling neural circuit reorganization and restoration of motor function.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eIn the pivotal clinical studies supporting FDA authorization, all 40 chronic stroke survivors who used IpsiHand\u0026trade; over a 12-week period demonstrated motor function improvement as measured by an increase in UEFM scores from baseline.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e To better understand the clinical utility of IpsiHand\u0026trade; in real-world use, a retrospective review of a quality assurance database was conducted for people with stroke who were prescribed IpsiHand\u0026trade; and opted to undergo regular UEFM assessments as part of routine clinical care.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis retrospective study analyzed de-identified patient data previously collected by the manufacturer\u0026rsquo;s team over a two-year period for quality assurance purposes. De-identified data included the date of first device use, the date of baseline UEFM score collection, baseline UEFM scores, and any subsequent UEFM scores with their respective collection dates. Demographic information was aggregated in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e following the analysis.\u003c/p\u003e \u003cp\u003eInclusion criteria included age between 18 and 85 years, stroke sustained at least six months prior to initial IpsiHand\u0026trade; use, prescription of IpsiHand\u0026trade; in accordance with its FDA-authorized indication, and exhibition of hemiparesis or hemiplegia as measured by cognitive function, language, motor function, and visual attention screening tests. Exclusion criteria included absence of a baseline UEFM score measurement and measurement of baseline UEFM score occurring more than one week after initiating device use.\u003c/p\u003e \u003cp\u003eThe primary data for this retrospective study was UEFM score measurements that were virtually assessed at approximate 6-week intervals for consenting subjects as part of routine stroke rehabilitation care. Given the irregularity of UEFM measurements in real-world use, only assessments conducted within \u0026plusmn;\u0026thinsp;1 week of the 6-, 12-, 18-, 24-week measurements were included in the analysis, with larger ranges of weeks used for the extended time points beyond 29 weeks. To mitigate missing data bias in the dataset, only entries with sufficient data to categorize the chronic stroke survivor as early responders, intermediate responders, and non-responders were included in the analysis. A\u0026thinsp;\u0026ge;\u0026thinsp;5.25 point change in the UEFM score was chosen as the threshold for clinically meaningful improvement based on existing literature and expert consensus.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eEarly responders were classified as those who achieved a\u0026thinsp;\u0026ge;\u0026thinsp;5.25-point increase in UEFM score at the 6-week measurement. Intermediate responders were classified as those who did not achieve MCID at 6 weeks but surpassed the MCID at 12 weeks. This classification required that both the 6-week and 12-week UEFM scores were measured for each IpsiHand\u0026trade; user. As such, 3 subjects with 12-week UEFM scores above MCID and missing 6-week scores were not included in the analysis, given the ambiguity in classification as an intermediate responder or early responder. Finally, early non-responders were classified as those who did not achieve a\u0026thinsp;\u0026ge;\u0026thinsp;5.25-point increase in UEFM score at the 12-week measurements. 19 subjects with only 6-week UEFM scores below MCID and missing 12-week scores were not included in the analysis, given the ambiguity in classification as an early non-responder or intermediate responder. After these exclusions, a total of 56 subjects were included in the analysis.\u003c/p\u003e \u003cp\u003eData analysis was conducted using Microsoft Excel and RStudio. Comparisons of the primary outcome were performed using Kruskal-Wallis tests. Post hoc analyses were conducted using Dunn\u0026rsquo;s tests with Bonferroni correction. Statistical significance was defined as a p-value of \u0026lt;\u0026thinsp;0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable 1: Patient Demographics Table\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"648\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;TOTAL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEarly responders\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEarly non-responders\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntermediate responders\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge (at Baseline Assessment)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emean (SD)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e61.7 (12.2)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e57.6 (12.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e65.9 (9.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e66.0 (13.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emedian (IQ1, IQ3)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e63.9 (53.6, 70.1)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e59.7 (46.0, 66.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e65.9 (58.0, 73.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e68.5 (54.6, 76.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003erange\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e32.8-82.7\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e32.8-77.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e50.7- 82.7\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e49.2- 81.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026ge;80 years of age, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e3 (5.4%)\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e2 (10.0%) \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e1 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003e65-79 years of age, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e18 (32.1%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e8 (27.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e8 (40.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e2 (28.6%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;50-64 years of age, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e21 (37.5%) \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e10 (34.5%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e9 (45.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e2 (28.6%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003e30-49 years of age, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e9 (16.1%) \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e8 (27.6%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e\u0026nbsp;0 (0.0%) \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e\u0026nbsp;1 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003e18-29 years of age, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e0 (0.0%) \u0026nbsp; \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e0 (0.0%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e0 (0.0%)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emissing, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e5 (8.9%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e3 (10.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e1 (5.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e1 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinical Characteristics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSide of Lesion\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003eleft, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e35 (62.5%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e19 (65.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e12 (60.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e4 (57.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003eright, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e20 (35.7%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e10 (34.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e8 (40.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e2 (28.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003eunknown, n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e1 (1.8%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e\u003cem\u003e0 (0.0%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e\u003cem\u003e0 (0.0%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e\u003cem\u003e1 (14.3%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline UEFM Score\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emean (SD)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e18.9 (12.8)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e18.7 (11.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e18.9 (14.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e20.3 (14.8)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emedian (IQ1, IQ3)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e16.0 (9.8, 25.0)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e18.0 (10.0, 22.0)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e14.5 (9.0, 25.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e17.0 (9.5, 25.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003erange\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e(3-61)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e(4-46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e(3-61)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e(8-47)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emild (UEFM \u0026ge; 43), n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e5 (8.9%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e\u003cem\u003e2 (7.4%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e2 (10.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e1 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003emoderate (UEFM = 29-42), n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e5 (8.9%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e\u003cem\u003e3 (11.1%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e1 (5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e1 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 26.8519%;\"\u003e\n \u003cp\u003e\u003cem\u003esevere (UEFM = 0-28), n (%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 14.8148%;\"\u003e\n \u003cp\u003e\u003cem\u003e46 (82.1%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 15.7407%;\"\u003e\n \u003cp\u003e\u003cem\u003e24 (88.9%)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 19.4444%;\"\u003e\n \u003cp\u003e17 (85.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 23.1481%;\"\u003e\n \u003cp\u003e5 (71.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cstrong\u003e\u003cem\u003eTable 2: Achievement of MCID over time\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u003cbr\u003e\u0026nbsp;The number and percentage of the 56 chronic stroke survivors who achieve or do not achieve the UEFM MCID of 5.25 points score change from baseline at the 6-week measurement and 12-week measurement, including those with missing data for either assessment week that did not create ambiguity in response classification.\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"568\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUEFM available at both 6 and 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e30\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e53%\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u0026gt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026gt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e40%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u0026gt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026lt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u0026lt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026gt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e23%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u0026lt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026lt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e37%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUEFM available at 6 weeks only\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e17\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e30%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u0026gt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUEFM available at 12 weeks only\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e16%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026lt;MCID\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSubjects \u0026gt;MCID within 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e64%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSubjects \u0026gt;MCID post 12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSubjects not \u0026gt;MCID TOTAL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e30%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSubjects \u0026gt;MCID TOTAL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 72px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 84px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 40px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e39\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e70%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eFirst, we sought to understand how early indication of a clinically significant UEFM score improvement may influence the durability of the score over time. Chronic stroke survivors using\u0026nbsp;IpsiHand\u0026trade; were categorized according to achievement of MCID at 6 or 12 weeks, and the reported changes in UEFM score from baseline for each group were averaged over time (\u003cstrong\u003eFigure 1\u003c/strong\u003e). To mitigate missing data biases, only subjects who could be assigned to three distinct categories were included in the analysis: early responder, intermediate responders, and early non-responders. Early responders (n=29)\u0026mdash;those who surpassed the UEFM MCID of at least 5.25 points change from baseline at the 6-week mark\u0026mdash;showed statistically significant improvement in upper extremity function on average over time compared to the early non-responders (n=20)\u0026mdash;those who fell short of the MCID by 6 or 12 weeks (Week 18, p=0.005; Week 24, p=0.016). Early responders showed numerically greater improvement in UEFM scores at 18 and 24 weeks on average as compared to the intermediate responders (n=7) \u0026mdash;those who did not surpass the MCID at 6 weeks but did at 12 weeks (\u003cstrong\u003eFigure 1\u003c/strong\u003e). A total of 64% (36/56) of the analyzed population derived meaningful clinical benefit by 12 weeks. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnalysis of longer durations of use beyond 12 weeks revealed the potential for functional improvement over time. In the early non-responder group, 35% (7/20) reported long-term UEFM scores between weeks 29 and 55. Of these subjects, 43% (3/7) revealed delayed achievement of the MCID (\u003cstrong\u003eTable 2\u003c/strong\u003e). Given that the remaining 65% (13/20) of early non-responders have not reported long-term UEFM scores beyond 29 weeks, the probability and time required for early non-responders to surpass the MCID threshold remains an open question. \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNext, we determined the overall IpsiHand\u0026trade; response rate over the course of time. Altogether, 70% ((29+7+3)/56) of the analysis population achieved the UEFM MCID using all reported UEFM scores out through 55 weeks (\u003cstrong\u003eTable 2\u003c/strong\u003e). Of the chronic stroke survivors with reported 6-week UEFM scores, 29/56 (52%) were early responders, surpassing the MCID by 6 weeks (\u003cstrong\u003eTable 2\u003c/strong\u003e). We note that all early responders with reported 12-week UEFM scores continued to surpass the MCID threshold after the 6-week assessment. An additional 39% (7/18) of subjects surpassed the MCID at 12 weeks despite failing to do so at 6 weeks, representing intermediate responders.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo more clearly contextualize the UEFM score change, we determined how many chronic stroke survivors transitioned between the following poststroke impairment categorizations defined by Woytowicz \u003cem\u003eet. al\u003c/em\u003e.:\u003ca id=\"_anchor_1\" href=\"#_msocom_1\" language=\"JavaScript\" name=\"_msoanchor_1\"\u003e\u003c/a\u003e severe (0-28), moderate (29-42), and mild (43-66). The baseline scores of the 56 chronic stroke survivors ranged from 3 to 61, with an average of 18.9 and a median of 16 (IQ1: 9.8, IQ3: 25) (\u003cstrong\u003eTable 1\u003c/strong\u003e). Most of the patient population in this study, 46/56 (82%), was classified as having severe poststroke motor impairments at baseline prior to initiating IpsiHand\u0026trade; therapy. For these chronic stroke survivors initiating IpsiHand\u0026trade; therapy with severe poststroke motor impairments, 15/46 (33%) transitioned to lower severity impairments over the course of therapy and 29/46 (63%) surpassing MCID by 12 weeks (\u003cstrong\u003eTable 3\u003c/strong\u003e). Of the 56 chronic stroke survivors with UEFM scores variably reported over 24 weeks, 10/46 (22%) reported sufficient data to indicate a transition from severe to moderate, 5/46 (11%) from severe to mild, and 1/5 (20%) from moderate to mild (\u003cstrong\u003eTable 3\u003c/strong\u003e). All of the remaining 5/56 chronic stroke survivors classified as having mild motor impairments at baseline demonstrated increase in UEFM score, with 3/5 (60%) reporting sufficient data to indicate that the MCID threshold was surpassed between 5-13 weeks.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eVagus Nerve Stimulation (VNS) has been shown to be effective in chronic stroke upper-extremity rehabilitation, however, the inclusion criteria in the pivotal clinical trial for Vivistim Paired VNS System specify a baseline UEFM of \u0026gt;20.\u003csup\u003e15\u003c/sup\u003e In this study, 36/56 (64%) of subjects started with a baseline UEFM score \u0026lt;20. We observed that 50% (18/36) of these subjects crossed the 20-point UEFM score threshold with IpsiHand\u0026trade; usage.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable 3: Reduction in post-stroke upper extremity impairment \u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u003cbr\u003e\u0026nbsp;The proportion of the 56 chronic stroke survivors with baseline UEFM measurements characterized as severe, moderate, or mild post-stroke motor impairments\u0026nbsp;\u003c/em\u003eper \u003cem\u003eWoytowicz et. al.: severe (0\u003c/em\u003e\u003cem\u003e-28), moderate (29\u003c/em\u003e\u003cem\u003e-42), and mild (43\u003c/em\u003e\u003cem\u003e-66)\u003c/em\u003e\u003cem\u003e. 16 cases where the available UEFM data over the 55-week period indicates an individual\u0026rsquo;s transition between categories are denoted.\u0026nbsp;\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"551\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 203px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 258px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnd Point UEFM Classification\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 203px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eInitial UEFM Classification\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cem\u003eSevere\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cem\u003eModerate\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cem\u003eMild\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 203px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;Baseline Severe\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e46/56 (82%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 203px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;Baseline Moderate\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e5/56 (9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 203px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;Baseline Mild\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 78px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 90px;\"\u003e\n \u003cp\u003e5/56 (9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eUse of IpsiHand\u0026trade; as part of real-world therapy in this study was associated with improvement in upper extremity function for 70% (39/56) of chronic stroke survivors with an average UEFM baseline score of 18.9. We observed several patterns of response, including 52% (29/56) of chronic stroke survivors exhibiting an early response within the first 6 weeks of use. Among IpsiHand\u0026trade; users who do not demonstrate a clinically meaningful response at 6 weeks, 39% (7/18) surpassed the MCID at the 12 weeks. For the early non-responders who did not achieve a clinically meaningful response by 6 or 12 weeks, the available reported data up to 55 weeks reveals the potential to achieve MCID after an extended period of therapy. The lack of regularly measured and reported UEFM scores, inherent to real-world evidence studies, yielded missing data inputs, which led to exclusion of IpsiHand\u0026trade; users from the analysis group given no data imputation was performed. Future clinical studies with more rigorous UEFM collection at each timepoint are required for more comprehensive analysis.\u003c/p\u003e \u003cp\u003eThe findings of this study are consistent with the clinical trials of IpsiHand\u0026trade; for FDA authorization for a similar patient population with less severe poststroke motor impairments on average (mean baseline UEFM score of 26.9 points, median of 24.5 points).\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e,\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e In the 12-week trial with IpsiHand\u0026trade;, used for 1 hour/day, 5 days/week, and over the course of 12 weeks, 18/26 (69%) subjects surpassed the MCID, and the mean increase in UEFM score was 8.1 points.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e In this real-world study, where patient adherence to recommended treatment guidelines was not enforced, 21/42 (50%) subjects with reported 12-week scores surpassed the MCID, and the mean increase in reported 12-week UEFM scores was 6.87 points. Including the subjects who are missing 12-week UEFM scores but whose 6-week UEFM scores surpass MCID, a total of 64% (39/56) of subjects surpassed MCID by 12 weeks.\u003c/p\u003e \u003cp\u003eThe results of this study suggest that IpsiHand\u0026trade; should be utilized for a minimum of 12 weeks to determine if a chronic stroke survivor can derive significant clinical benefit and if early responders continue to improve, with evidence of clinically meaningful responses achieved after longer (\u0026gt;\u0026thinsp;12 week) periods of therapy. We propose to conduct future studies to identify predictors of patient response to IpsiHand\u0026trade; therapy, including individualized estimates of the potential extent of motor recovery possible and expected time to achieve MCID. The continued collection of this real-world evidence is crucial to further explore long-term functional improvement enabled by IpsiHand\u0026trade; for chronic stroke survivors.\u003c/p\u003e\n\u003ch3\u003eLimitations\u003c/h3\u003e\n\u003cp\u003eThe primary limitation of this study is the retrospective analysis of data, as it was collected from individuals who participated in a quality assurance program to provide feedback to users. Given the goal of assessing real-world use of the device, we anticipate variability in IpsiHand\u0026trade; usage patterns, specifically in the number of sessions, session durations, and repetitions completed per session, which may impact the extent and time required to achieve meaningful clinical benefit. Additionally, a limitation of the UEFM outcome measure is the potential for study participants to achieve the MCID not through motor recovery of the affected limb, but rather through the development of compensatory motor patterns, such as increasing bilateral upper extremity movements or increasing unilateral movements of the non-paretic upper extremity.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis retrospective real-world evidence study demonstrates that chronic stroke survivors (6 months post-stroke), including those classified as having severe motor impairments at baseline, can achieve clinically meaningful functional improvement through use of IpsiHand\u0026trade;. For chronic stroke survivors who derive clinical benefit by 6 weeks, UEFM scores were observed to increase further over 12 and 24 weeks. Even among those who did not exhibit MCID by 6 weeks, a significant portion were observed to surpass this threshold by 12 weeks and sustain the improvement over time. For chronic stroke survivors who did not derive meaningful clinical benefit at 12 weeks, limited data suggests that the possibility of future recovery remains open.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBCI: Brain-Computer Interface\u003c/p\u003e\n\u003cp\u003eMCID: Minimal Clinically Important Difference\u003c/p\u003e\n\u003cp\u003eUEFM:\u0026nbsp;Upper Extremity Fugl-Meyer Assessments\u003c/p\u003e\n\u003cp\u003eVNS: Vagus Nerve Stimulation\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics Approval and Consent to Participate\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll participants provided written/verbal consent to participation, and the study was determined to be exempt from Institutional Review Board oversight by the WCG IRB. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for Publication\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData Availability\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe data generated and analyzed in this study are not publicly available to protect patient information but are available from the corresponding author on reasonable request. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConflict of Interest/Competing Interests\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eN.K.P., L.A.F., A.L.G. and N.J.P. are employees of Rubrum Advising, which is under contract with Neurolutions, Inc., and L.P., L.S., and S.J.W. are employees of Neurolutions, Inc.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis work was funded by Neurolutions, Inc. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAuthors would like to thank the study participants for their contributions.\u0026nbsp;\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eS.J.W, L.A.F., L.S., and L.P. led the conception and design of the work. N.K.P. and N.J.P. led the analysis of the data. S.J.W., L.A.F, L.S., and L.P. contributed to the interpretation of the data. A.L.G. drafted the work and substantial revisions were provided by N.K.P., L.A.F., and S.J.W.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHow many people are affected by/at risk for stroke? 2024. https://www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk\u003c/li\u003e\n\u003cli\u003eVillarroel M, Blackwell D, Jen A. \u003cem\u003eTables of Summary Health Statistics for U.S. Adults: 2018 National Health Interview Survey\u003c/em\u003e. 2019. http://www.cdc.gov/nchs/nhis/SHS/tables.htm.\u003c/li\u003e\n\u003cli\u003eTsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics\u0026mdash;2023 Update: A Report From the American Heart Association. \u003cem\u003eCirculation\u003c/em\u003e. 2023;147(8):e93-e621. doi:doi:10.1161/CIR.0000000000001123\u003c/li\u003e\n\u003cli\u003eLang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. \u003cem\u003eJ Hand Ther\u003c/em\u003e. Apr-Jun 2013;26(2):104-14;quiz 115. doi:10.1016/j.jht.2012.06.005\u003c/li\u003e\n\u003cli\u003eKwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. \u003cem\u003eStroke\u003c/em\u003e. 2003;34(9):2181-2186. \u003c/li\u003e\n\u003cli\u003eNishimura Y, Onoe H, Morichika Y, Perfiliev S, Tsukada H, Isa T. Time-dependent central compensatory mechanisms of finger dexterity after spinal cord injury. \u003cem\u003eScience\u003c/em\u003e. 2007;318(5853):1150-1155. \u003c/li\u003e\n\u003cli\u003eBernhardt J, Hayward KS, Kwakkel G, et al. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. \u003cem\u003eInt J Stroke\u003c/em\u003e. Jul 2017;12(5):444-450. doi:10.1177/1747493017711816\u003c/li\u003e\n\u003cli\u003eH N, HS J, HO R, TS O. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study - PubMed. \u003cem\u003eArchives of physical medicine and rehabilitation\u003c/em\u003e. 1994 Apr;75(4)doi:10.1016/0003-9993(94)90161-9\u003c/li\u003e\n\u003cli\u003eFugl-Meyer AR, J\u0026auml;\u0026auml;sk\u0026ouml; L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. \u003cem\u003eScand J Rehabil Med\u003c/em\u003e. 1975;7(1):13-31. \u003c/li\u003e\n\u003cli\u003eGladstone DJ, Danells CJ, Black SE. The Fugl-Meyer Assessment of Motor Recovery after Stroke: A Critical Review of Its Measurement Properties. \u003cem\u003eNeurorehabilitation and Neural Repair\u003c/em\u003e. 2002;16(3):232-240. doi:10.1177/154596802401105171\u003c/li\u003e\n\u003cli\u003eRech KD, Salazar AP, Marchese RR, Schifino G, Cimolin V, Pagnussat AS. Fugl-Meyer Assessment Scores Are Related With Kinematic Measures in People with Chronic Hemiparesis after Stroke. \u003cem\u003eJournal of Stroke and Cerebrovascular Diseases\u003c/em\u003e. 2020/01/01/ 2020;29(1):104463. doi:https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.104463\u003c/li\u003e\n\u003cli\u003eUS Food and Drug Administration. Neurolutions IpsiHand: De Novo Classification Approval Letter. 2020.\u003c/li\u003e\n\u003cli\u003eRustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. \u003cem\u003eNeurorehabil Neural Repair\u003c/em\u003e. Sep 30 2024:15459683241287731. doi:10.1177/15459683241287731\u003c/li\u003e\n\u003cli\u003ePage SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. \u003cem\u003ePhys Ther\u003c/em\u003e. Jun 2012;92(6):791-8. doi:10.2522/ptj.20110009\u003c/li\u003e\n\u003cli\u003ePMA P210007: FDA Summary of Safety and Effectiveness Data (2021).\u003c/li\u003e\n\u003cli\u003eBundy DT, Souders L, Baranyai K, et al. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. \u003cem\u003eStroke\u003c/em\u003e. Jul 2017;48(7):1908-1915. doi:10.1161/strokeaha.116.016304\u003c/li\u003e\n\u003cli\u003eRustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. \u003cem\u003eNeurorehabil Neural Repair\u003c/em\u003e. Jan 2025;39(1):74-86. doi:10.1177/15459683241287731\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-neuroengineering-and-rehabilitation","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jner","sideBox":"Learn more about [Journal of NeuroEngineering and Rehabilitation](http://jneuroengrehab.biomedcentral.com/)","snPcode":"12984","submissionUrl":"https://submission.nature.com/new-submission/12984/3","title":"Journal of NeuroEngineering and Rehabilitation","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Chronic Stroke Rehabilitation, Brain-Computer Interface, IpsiHand, Upper Extremity Motor Function","lastPublishedDoi":"10.21203/rs.3.rs-6305433/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6305433/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThe IpsiHand\u0026trade; System is an FDA-authorized, non-invasive therapy for chronic stroke-induced motor impairment that leverages a brain-computer interface (BCI) to actuate ipsilateral intent-to-move signals. This study aimed to use real-world evidence to determine device effectiveness when used by stroke survivors at least 6 months after stroke onset. A quality assurance database was retrospectively reviewed for chronic stroke survivors who were prescribed IpsiHand\u0026trade; and opted to receive regular Upper Extremity Fugl-Meyer Assessments (UEFM) as part of routine clinical care. Early responders, who achieved the minimal clinically important difference (MCID) of 5.25 points from the baseline UEFM score by 6 weeks of use, showed statistically significant continuous improvement in upper extremity function over time as compared to early non-responders, who did not surpass the MCID by 12 weeks. Additionally, early responders showed greater UEFM score improvement compared to intermediate responders, defined as those who did not surpass the MCID until 12 weeks. Altogether, 70% (39/56) of the analysis population achieved the UEFM MCID using all reported UEFM scores out through 55 weeks. The results suggest that IpsiHand\u0026trade; therapy should be utilized for a minimum of 12 weeks to determine if a chronic stroke survivor can derive significant clinical benefit, with evidence of individuals achieving clinically meaningful response after longer periods of therapy. The continued collection of real-world evidence is crucial to further explore long-term functional improvement enabled by IpsiHand\u0026trade; and establish predictive characteristics of responders.\u003c/p\u003e","manuscriptTitle":"A Retrospective Analysis of Post-Stroke Rehabilitation with Real World Use of Brain- Computer Interface","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-02 05:33:38","doi":"10.21203/rs.3.rs-6305433/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-06-30T19:26:52+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-29T06:21:33+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-25T08:42:58+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-11T13:31:50+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"289429876906086184281714126339863304405","date":"2025-06-11T05:53:58+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"232266771429759056247556253021390792549","date":"2025-06-09T15:39:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"199419994546951745734340432607918910011","date":"2025-06-09T06:11:33+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-06-09T05:26:16+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-25T23:11:07+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-25T23:10:09+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of NeuroEngineering and Rehabilitation","date":"2025-03-25T15:47:09+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-neuroengineering-and-rehabilitation","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jner","sideBox":"Learn more about [Journal of NeuroEngineering and Rehabilitation](http://jneuroengrehab.biomedcentral.com/)","snPcode":"12984","submissionUrl":"https://submission.nature.com/new-submission/12984/3","title":"Journal of NeuroEngineering and Rehabilitation","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"01f0fb7a-4707-4afa-a83c-5ddaaaa5d993","owner":[],"postedDate":"April 2nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-01-26T16:01:17+00:00","versionOfRecord":{"articleIdentity":"rs-6305433","link":"https://doi.org/10.1186/s12984-026-01880-4","journal":{"identity":"journal-of-neuroengineering-and-rehabilitation","isVorOnly":false,"title":"Journal of NeuroEngineering and Rehabilitation"},"publishedOn":"2026-01-21 15:58:12","publishedOnDateReadable":"January 21st, 2026"},"versionCreatedAt":"2025-04-02 05:33:38","video":"","vorDoi":"10.1186/s12984-026-01880-4","vorDoiUrl":"https://doi.org/10.1186/s12984-026-01880-4","workflowStages":[]},"version":"v1","identity":"rs-6305433","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6305433","identity":"rs-6305433","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}