Home Based Functional Balance Intervention for Multiple Sclerosis
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: Ex
| Condition(s) | Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive, Multiple Sclerosis Acute and Progressive |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 signif |
| Who can participate | Inclusion Criteria Telephone Screening Inclusion Criteria: 1. Age 40-90 years. 2. Self-reported diagnosis of Multiple Sclerosis. 3. On stable disease-modifying therapy for ≥6 months. 4. No PT/OT balance-related therapy in the past 6 months. 5. Able to stand from a chair independently (with or without hand support). 6. Score 25-75% on the 12-item MS Walking Scale. 7. No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing/walking. 8. English speaking. 9. Willing to complete all study procedures including Zoom sessions. 10. Has reliable internet access. 11. Has a helper buddy available for all sessions. 12. Possible mild cognitive impairment based on self-report. Initial Screening Inclusion Criteria: 1. Moderate disability: ePR-EDSS score 4.0-6.5. 2 |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Lead sponsor | University of Illinois at Chicago |
| Locations | Chicago, Illinois, United States |
| Start date | 2025-11-24 |
| NCT ID | NCT07355387 |
| Official listing | https://clinicaltrials.gov/study/NCT07355387 |