Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People with Parkinson’s Disease: a Single-Blind Randomized Controlled Trial Protocol

Background Freezing of gait (FOG) is a common motor symptom in Parkinson’s disease (PD), increasing the risk of falls and reducing independence and quality of life. Effective management combines pharmacological treatment and, when necessary, surgical intervention with targeted strategies aimed at improving gait through compensatory brain networks. Mental Practice (MP), which consists of mentally rehearsing movements, has been studied as a possible strategy to facilitate gait through goal-directed motor control. However, there is limited evidence regarding its therapeutic effects on FOG. This study aims to compare the effects of a novel intervention combining MP based on Dynamic Neuro-Cognitive Imagery (DNI) and Physical Practice (PP) with a control intervention involving PP only, both delivered remotely on the severity of FOG episodes in individuals with PD.

A single-blind, controlled, and randomized trial is proposed. People with idiopathic PD who answered positively to the first question of New Freezing of Gait Questionnaire (NFOG-Q) will be randomly allocated into the Experimental Group (EG) and Control Group (CG). Both groups will undergo 10 remote intervention sessions lasting 45 - 60 minutes with identical volume and intensity, differing only in the MP components. The EG will perform sessions of MP combined with PP, while the CG will perform sessions of PP and stretching. They will be assessed before intervention (BI), after intervention (AI), and 30 days after the intervention, as a follow-up (FU). Primary outcomes included the time to complete the Rapid Turn Test, and the Percentage of time spent with FOG during the test (%FOG). Secondary outcomes included the NFOG-Q, the Movement Disorders Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), the Parkinson’s Disease Questionnaire-39 (PDQ-39), and the Telephone Montreal Cognitive Assessment (T-MoCA). A repeated measures ANOVA will be used for statistical analysis.

The main hypothesis is that both interventions, which are similar in terms of volume, intensity, and progression of complexity, will positively affect the FOG severity. However, experimental intervention combining MP and PP is expected to produce better outcomes than the control intervention. If this hypothesis is confirmed, the study could significantly impact the treatment of people with PD by providing a low-cost and widely accessible option. Administrative information Note: The numbers in curly bracelets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items. Competing Interest Statement The authors have declared no competing interest. Clinical Trial The study has been registered on ClinicalTrials.gov and is currently awaiting the assignment of the NCT number following review. Attached is the official submission receipt (PRS Draft Receipt). Funding Statement This study is funded by the Sao Paulo Research Foundation (FAPESP) through the Research, Innovation and Dissemination Center for Neuromathematics (CEPID NeuroMat, grant number 2013/07699-0). FAPESP had no role in the study design, data collection, management, analysis, or interpretation of the data; writing of the protocol; or the decision to submit the results for publication. All scientific and operational decisions were made independently by the authors of the protocol. 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: The Research Ethics Committee of the Faculty of Medicine of the University of Sao Paulo gave ethical approval for this work (number 7.253.458). 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 Data Availability All data produced in the present work are contained in the manuscript. Abbreviations - PD - Parkinson’s disease - FOG - Freezing of Gait - AOT - Action Observation Training - MP - Mental Practice - PP - Physical Practice - fMRI - Functional Magnetic Resonance Imaging - TUG - Time UP and Go - DNI - Dynamic Neuro-Cognitive Imagery - CI - Control Intervention - SPIRIT - Standard Protocol Items: Recommendations for Interventional Trials - LEED - Levodopa Equivalent Daily Dose - NFOG-Q - New Freezing of Gait Questionnaire - T-MoCA - Telephone Montreal Cognitive Assessment - KVIQ-20 - Kinesthetic and Visual Imagery Questionnaire - 20 - EI - Experimental Intervention - BI - Before Intervention - AI - After Intervention - FU - Follow-up - %FOG - Percentage of time spent with FOG during the task - MDS-UPDRS - Movement Disorders Society - Unified Parkinson’s Disease Rating Scale - PDQ-39 - Parkinson Disease Questionnaire - 39 - ES - Effect Size - REDE AMPARO - Neuromat Support Network for Friends and Individuals with PD - EG - Experimental Group - CG - Control Group