NCT07355387Recruiting

Home Based Functional Balance Intervention for Multiple Sclerosis

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

Source: ClinicalTrials.gov · Last updated 21 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 75 (estimated)
First submitted: 1 Dec 2025
Start date: 24 Nov 2025
Primary completion date: 24 Nov 2026
Lead sponsor: University of Illinois Chicago
Diseases: Multiple sclerosis
NCT number: NCT07355387

What you commit to

Study type: Interventional
Planned participants: 75
From 24 Nov 2025 to the primary completion date, 24 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Recent major surgery (\<6 months) or hospitalization (\<3 months).
Sedative medication use that may interfere with training.
Use of antidepressants or anxiety medications.
Currently receiving cognitive or physical rehabilitation.

Other illness

Uncontrolled hypertension or diabetes.
History of epilepsy or uncontrolled seizures in past year.
Use of Alzheimer's/dementia-modifying drugs or enrollment in AD clinical trials.
Severe cognitive impairment (TICS-M ≥18).

Other

Telephone Screening Exclusion Criteria:
MS relapse or exacerbation within the past 3 months.
Resting shortness of breath or uncontrolled pain \>3/10.
Bone fracture in the past 6 months.
Disability limiting activities of daily living.
Moderate or high risk on PAR-Q (≤1 "yes" response).
Pacemaker use.
- Initial Screening Exclusion Criteria:
Cardiovascular parameters outside safety limits (HR, BP, O₂ saturation).
Global aphasia (Mississippi \<71 percent).
Peripheral nerve injury.
Berg Balance Scale \<40/56.
Inability to walk one block with or without an assistive device.
- Population Exclusions:
Non-English speakers (protocol delivered only in English).
Individuals under 18 years.
Pregnant individuals.
Prisoners or other vulnerable populations.

Who the study is looking for

Telephone Screening Inclusion Criteria:
Age 40-90 years.
Self-reported diagnosis of Multiple Sclerosis.
On stable disease-modifying therapy for ≥6 months.
No PT/OT balance-related therapy in the past 6 months.
Able to stand from a chair independently (with or without hand support).
Score 25-75% on the 12-item MS Walking Scale.
No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing/walking.
English speaking.
Willing to complete all study procedures including Zoom sessions.
Has reliable internet access.
Has a helper buddy available for all sessions.
Possible mild cognitive impairment based on self-report.
- Initial Screening Inclusion Criteria:
Moderate disability: ePR-EDSS score 4.0-6.5.
Mild cognitive impairment: MoCA 18-25, or Jak/Bondi criteria for those scoring 26-30.
Physically inactive or moderately active (Godin score \<24).
Cardiovascular safety parameters within acceptable limits.
No global aphasia (Mississippi Aphasia Screening Test ≥71 percent).
Berg Balance Scale score ≥40/56.
Able to walk 1 block with or without an assistive device.
- Helper Buddy Inclusion Criteria:
Age ≥18 years.
Lives within close proximity to the participant.
No self-reported major medical conditions limiting safety assistance.
English speaking.
Able to attend all training and assessment sessions.
Able to assist with basic safety, positioning, and communication with the research team.
Has internet access and can use Zoom.

Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Illinois at Chicago Coordinator of this site? Confirm its status	Chicago	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.