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RECRUITING

NCT07355387

Home Based Functional Balance Intervention for Multiple Sclerosis

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-24

Completion Date

2027-11-24

Last Updated

2026-01-21

Healthy Volunteers

Conditions

Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis (MS) Primary Progressive Multiple Sclerosis (MS) Secondary Progressive Multiple Sclerosis Acute and Progressive

Interventions

BEHAVIORAL

Multicomponent balance intervention consisting of four components including dual-tasking, functional strength, vestibular and dynamic balance.

The Functional Balance Intervention (FBI) is a multicomponent, home based cognitive motor training program designed specifically for persons with Multiple Sclerosis. It integrates four structured constructs-functional agility, functional strength, dual task cognitive motor exercises, and vestibular training-within each 1 hour session. The program uses custom designed interactive dual task stepping games that require simultaneous motor stepping responses and cognitive tasks such as arithmetic, category fluency, and visuospatial cue discrimination. Vestibular components include gaze stabilization, head turn walking, and figure of eight patterns. Progression is individualized using predefined home evaluation criteria (step count, chair stands, tandem stance, single leg stance, and perceived stability). Training is completed independently at home with a helper buddy present and supported by weekly Zoom sessions.

BEHAVIORAL

Stretching

The stretching program is a non-progressive, home based flexibility protocol designed to serve as an active control condition. Unlike the Functional Balance Intervention, this program does not include agility, strength, dual task, vestibular, or cognitive motor components, and it does not use computerized games or progressive home evaluations. Participants complete 1 hour sessions, 2 days per week for 4 months, consisting solely of static stretches targeting major upper extremity, lower extremity, trunk, and back muscle groups. All stretches are performed in standing to match the positional demands and session duration of the experimental arm without engaging balance or cognitive systems. The program emphasizes gentle range of motion, posture, breathing, and relaxation rather than neuromotor challenge. No equipment is required beyond the printed stretching manual, and exercises do not progress in complexity or intensity.

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.

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States