Home-based functional balance program for people with multiple sclerosis

Home Based Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis

This project will test whether a home-based functional balance program helps adults with multiple sclerosis improve physical and cognitive function and daily activities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 40 Years to 90 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07355387 on ClinicalTrials.gov

What this trial studies

This is a two-arm, Phase 1 randomized controlled trial comparing a multicomponent Functional Balance Intervention (FBI) delivered at home to a stretching control program over four months. Participants and a designated helper buddy complete remote onboarding, then perform independent home training with remote monitoring and safety checks. The FBI includes dual-task, functional strength, vestibular, and dynamic balance components, while the control group follows a stretching program. The study will measure changes in physical function, cognitive function, and activities of daily living, and will assess feasibility and safety.

Who should consider this trial

Good fit: Adults aged 40–90 with a self-reported MS diagnosis, moderate disability (ePR-EDSS 4.0–6.5), possible mild cognitive impairment, stable on disease-modifying therapy, with reliable internet access and a helper buddy available.

Not a fit: People with severe disability outside the enrolled ePR-EDSS range, major comorbidities affecting standing or walking, no internet or helper available, recent balance-focused PT/OT, or unstable cardiovascular conditions are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could offer a convenient home-based way for people with MS to improve balance, mobility, cognition, and daily functioning.

How similar studies have performed: Prior telerehabilitation and balance exercise studies in MS have shown modest improvements in mobility and function, but multicomponent home-based programs combining dual-task, vestibular, and strength training remain relatively untested.

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.

Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: Tanvi Bhatt, PhD

Conditions: Multiple Sclerosis, Multiple Sclerosis - Relapsing-remitting, Multiple Sclerosis Primary Progressive, Multiple Sclerosis Secondary Progressive, Multiple Sclerosis Acute and Progressive, Home based rehabilitation, Telerehabilitation, Mild cognitive impairment