Home-based functional balance program for people with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Tanvi Bhatt, PhD
• Email: tbhhat6@uic.edu
• Phone: 3124139772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using short selfie videos to measure walking and speech changes in people with MS

  This project will test whether short selfie videos taken by people with MS can reliably show walking and speech changes similar to what clinicians see in person.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07222618

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Safety and dosing of S103 cells in progressive or refractory multiple sclerosis

  This trial tests S103 BCMA-CAR T cells in adults with progressive or refractory MS to see if it can be safely given and hint at benefit.

  Recruiting Phase 1 Xijing Hospital · Xi'an, Shaanxi · NCT07587125

• TRX319 treatment for people with primary or secondary progressive multiple sclerosis

  This trial will test whether the experimental therapy TRX319, given with or without a short bendamustine pre-conditioning, is safe and can slow or improve disability in adults with primary or secondary progressive MS.

  Recruiting at 8 sites Phase 1/2 Tr1X, Inc. · La Jolla, California and 7 other locations · NCT07477639

• Ublituximab (Briumvi) for early relapsing MS

  This study will test whether giving Ublituximab (Briumvi) about twice a year is safe and changes a blood marker (neurofilament light) in adults with early relapsing MS.

  Recruiting Phase 4 Northwestern University · Chicago, Illinois · NCT07225361

• Sexual problems in women with relapsing-remitting multiple sclerosis

  See if sexual dysfunction is common in women aged 25-50 with relapsing-remitting MS and whether it's linked to fatigue, mood, bladder symptoms, and cognitive problems.

  Recruiting Ege University · Izmir, Bornova · NCT07193823

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.