Home Based Functional Balance Intervention for Multiple Sclerosis

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.

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.

Sponsors & Collaborators

• University of Illinois at Chicago

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-24

Primary Completion

2026-11-24

Completion

2027-11-24

Countries

• United States

Study Locations