Characterizing Response to Personalized Intervention in Lower Limb Prosthesis Users: A Sensor-Based Approach to Rehabilitation

Question Can a personalized post-rehabilitation intervention, guided by wearable sensor data, clinical outcomes, and expert review, improve functional mobility in individuals with lower limb amputation (LLA) who exhibit unmet mobility needs? Design Prospective observational study with a nested intervention. Participants Fifty-eight adults with LLA, recruited from military and civilian sites. Based on three months of community-based monitoring and clinical assessments, an expert panel identified 26 individuals as requiring additional support; 19 completed the intervention. Intervention Tailored combinations of physical therapy, prosthetic adjustments, and/or motivational interviewing delivered over three months based on individual needs and goals. Outcome Measures Performance-based tests, patient-reported outcomes, daily step count, and progress toward self-defined mobility goals. Change from baseline was assessed using minimal clinically important difference (MCID) thresholds. Between-group comparisons (Responders vs Non-Responders), and equivalence testing with a non-intervention group were conducted.

Following intervention, 68% of participants improved in functional outcomes, goal attainment, or both. Among Responders, 46% exceeded the MCID for sit-to-stand performance, with 17– 33% meeting thresholds for other mobility and quality-of-life measures. Responders had lower body mass index, fewer comorbidities, showed greater gains in step count, physical performance and prosthesis-related quality of life. Equivalence testing showed Amputee Mobility Predictor scores among Sustained Responders became statistically comparable to those who never required intervention. Most participants maintained gains at follow-up.

A personalized intervention approach guided by integrated data and experts review may improve real-world outcomes in individuals with LLA. These findings support reassessment to identify residual needs and deliver targeted support beyond standard care. Competing Interest Statement The authors have declared no competing interest. Clinical Trial NCT03930199 Funding Statement This work was supported by the Department of Defense through the Congressionally Directed Medical Research Programs, Orthotics and Prosthetics Outcomes Research Program under Award No. W81XWH-18-2-0057. The views expressed are those of the authors, and do not necessarily reflect the official policy or position of the Defense Health nor the U.S. government. The identification of specific products or scientific instrumentation does not constitute endorsement or implied endorsement on the part of the authors, Department of Defense, or any component agency. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the Institutional Review Boards of all participating sites: Shirley Ryan AbilityLab (STU00208186), Minneapolis VA Health Care System (VAM-18-00362), and Walter Reed National Military Medical Center (WRNMMC-2019-0226). All participants provided written informed consent prior to participation. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Author emails: Sara Nataletti: snataletti{at}sralab.org ; Jennifer Bartloff: jbartloff{at}sralab.org ; Juan Cave: Juan.Cave{at}va.gov ; Henry Wyneken: Henry.Wyneken{at}va.gov; Amber Wacek: amber.wacek{at}va.gov ; Matthew McGuire: mmcguire{at}sralab.org ; Shenan Hoppe-Ludwig: shoppeludw{at}sralab.org ; Anushua Banerjee: abanerjee{at}sralab.org ; Rachel Maronati: rachelmaronati{at}gmail.com ; Brad D. Hendershot: bradford.d.hendershot2.civ{at}health.mil ; John M. Looft: John.Looft{at}va.gov Clinical Trial Registration Number: NCT03930199 Data Availability All data produced in the present study are available upon reasonable request to the authors