The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.
Age range
40 Years – 90 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety: occurrence of adverse events
Timeframe: Last week of training (Month 4)
Adherence
Timeframe: End of training (Month 4)
Change in Physical Function measured by Short Physical Performance Battery
Timeframe: Baseline, 1 week post-training
Change in Walking Function: Dynamic Gait Index (DGI)
Timeframe: Baseline, 1 week post-training
Change in Walking endurance: Timed 25-Foot Walk
Timeframe: Baseline, 1 week post-training
Change in information processing speed
Timeframe: Baseline, 1 week post-training
Change in verbal learning and memory
Timeframe: Baseline, 1 week post-training
Change in visuospatial learning and memory
Timeframe: Baseline, 1 week post-training
Change in Dual-task balance cost
Timeframe: Baseline, 1 week post-training
Change in Community Mobility: University of Alabama Birmingham (UAB) Questionnaire
Timeframe: Baseline, 1 week post-training
Change in Community Mobility: Accelerometer
Timeframe: Baseline, 1 week post-training
Change in Quality of Life: Multiple Sclerosis Impact Scale (MSIS-29)
Timeframe: Baseline, 1 week post-training
Change in Balance Confidence: Activities-Specific Balance Confidence (ABC)
Timeframe: Baseline, 1 week post-training