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Home Based Functional Balance Intervention for Multiple Sclerosis
NCT07355387 · University of Illinois at Chicago
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Home Based Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis
About this study
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.
Eligibility criteria
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. Mild cognitive impairment: MoCA 18-25, or Jak/Bondi criteria for those scoring 26-30.
3. Physically inactive or moderately active (Godin score \<24).
4. Cardiovascular safety parameters within acceptable limits.
5. No global aphasia (Mississippi Aphasia Screening Test ≥71 percent).
6. Berg Balance Scale score ≥40/56.
7. Able to walk 1 block with or without an assistive device.
Helper Buddy Inclusion Criteria:
1. Age ≥18 years.
2. Lives within close proximity to the participant.
3. No self-reported major medical conditions limiting safety assistance.
4. English speaking.
5. Able to attend all training and assessment sessions.
6. Able to assist with basic safety, positioning, and communication with the research team.
7. Has internet access and can use Zoom.
Exclusion Criteria
Telephone Screening Exclusion Criteria:
1. MS relapse or exacerbation within the past 3 months.
2. Recent major surgery (\<6 months) or hospitalization (\<3 months).
3. Resting shortness of breath or uncontrolled pain \>3/10.
4. Uncontrolled hypertension or diabetes.
5. Bone fracture in the past 6 months.
6. Disability limiting activities of daily living.
7. History of epilepsy or uncontrolled seizures in past year.
8. Sedative medication use that may interfere with training.
9. Use of Alzheimer's/dementia-modifying drugs or enrollment in AD clinical trials.
10. Use of antidepressants or anxiety medications.
11. Moderate or high risk on PAR-Q (≤1 "yes" response).
12. Severe cognitive impairment (TICS-M ≥18).
13. Currently receiving cognitive or physical rehabilitation.
14. Pacemaker use.
Initial Screening Exclusion Criteria:
1. Cardiovascular parameters outside safety limits (HR, BP, O₂ saturation).
2. Global aphasia (Mississippi \<71 percent).
3. Peripheral nerve injury.
4. Berg Balance Scale \<40/56.
5. Inability to walk one block with or without an assistive device.
Population Exclusions:
1. Non-English speakers (protocol delivered only in English).
2. Individuals under 18 years.
3. Pregnant individuals.
4. Prisoners or other vulnerable populations.
Study design
Enrollment target: 75 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-11-24
Estimated completion: 2027-11-24
Last updated: 2026-01-21
Interventions
Behavioral: Multicomponent balance intervention consisting of four components including dual-tasking, functional strength, vestibular and dynamic balance.Behavioral: Stretching
Primary outcomes
- • Safety: occurrence of adverse events (Last week of training (Month 4))
- • Adherence (End of training (Month 4))
- • Change in Physical Function measured by Short Physical Performance Battery (Baseline, 1 week post-training)
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactTanvi Bhatt, PhD · contact · tbhhat6@uic.edu · 3124139772
ContactRudri Purohit, PhD · contact · rpuroh2@uic.edu · 3128773640
All locations (1)
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States