This project investigates the feasibility of a remote, home-based Functional Balance Intervention (FBI) targeting the physical and cognitive symptoms of multiple sclerosis (MS).
The study is a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of the FBI on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Because the exercise training will be completed independently at home, additional precautionary measures for participant safety (such as requiring a Helper Buddy) and modified home evaluations will be implemented to monitor training progression.
A total of 75 people with multiple sclerosis (PwMS) will be recruited and undergo a telephone screening. Accounting for an estimated 20% screening failure rate, the investigators expect to enroll approximately 60 PwMS in the project. Based on an additional 20% expected attrition following the initial screening, approximately 48 PwMS are anticipated to be eligible for participation. Eligible participants will complete one pre-training assessment session before being randomized into one of two groups: the FBI (Intervention Group) or the Stretching (Control) group.
Following randomization, each participant and their designated Helper Buddy will complete an onboarding session that provides detailed instructions regarding assessment procedures and training logistics. Participants will then engage in independent training sessions with their Helper Buddy twice per week for four months. Given the expected 15-17% attrition rate based on prior experience, the target final sample size is 40 PwMS. The investigators expect 40 participants to complete post-training assessments after four months and finish the study.
All assessment sessions will be conducted virtually via Zoom. Measures collected during the initial screening, pre-training assessment, training progression checks, and post-training assessment will occur either via Zoom with a Helper Buddy present or through survey links distributed via the University of Illinois REDCap system. Training sessions will be performed independently by participants in the presence of their Helper Buddy.
The overall goal of this project is to determine the feasibility of the FBI and evaluate its impact on physical and cognitive functions, as well as other measures of daily living among PwMS in a home-based environment. This protocol builds on strong evidence from previous successful trials involving neurological populations. It has been piloted in a laboratory setting with individuals with stroke and mild cognitive impairment, demonstrating both safety and efficacy. In addition, it has been tested in telerehabilitation formats among healthy older adults and frail older individuals, with results indicating feasibility, safety, and effectiveness for independent home exercise and no reported adverse events.
The investigators now intend to translate this evidence-based protocol to examine its effects in people with multiple sclerosis. If successful, this study could have substantial impact by providing a low-cost, safe, and effective intervention that increases accessibility for rural and underserved populations.
