Home Based Functional Balance Intervention for Multiple Sclerosis (HomeFBIinMS)

University of Illinois

Status: Enrolling

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

Treatments: Behavioral: Multicomponent balance intervention consisting of four components including dual-tasking, functional strength, vestibular and dynamic balance.; Behavioral: Stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT07355387

2025-0796

Details and patient eligibility

About

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.

Full description

This project investigates the feasibility of a remote, home-based Functional Balance Intervention (FBI) targeting the physical and cognitive symptoms of multiple sclerosis (MS).

The study is a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of the FBI on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Because the exercise training will be completed independently at home, additional precautionary measures for participant safety (such as requiring a Helper Buddy) and modified home evaluations will be implemented to monitor training progression.

A total of 75 people with multiple sclerosis (PwMS) will be recruited and undergo a telephone screening. Accounting for an estimated 20% screening failure rate, the investigators expect to enroll approximately 60 PwMS in the project. Based on an additional 20% expected attrition following the initial screening, approximately 48 PwMS are anticipated to be eligible for participation. Eligible participants will complete one pre-training assessment session before being randomized into one of two groups: the FBI (Intervention Group) or the Stretching (Control) group.

Following randomization, each participant and their designated Helper Buddy will complete an onboarding session that provides detailed instructions regarding assessment procedures and training logistics. Participants will then engage in independent training sessions with their Helper Buddy twice per week for four months. Given the expected 15-17% attrition rate based on prior experience, the target final sample size is 40 PwMS. The investigators expect 40 participants to complete post-training assessments after four months and finish the study.

All assessment sessions will be conducted virtually via Zoom. Measures collected during the initial screening, pre-training assessment, training progression checks, and post-training assessment will occur either via Zoom with a Helper Buddy present or through survey links distributed via the University of Illinois REDCap system. Training sessions will be performed independently by participants in the presence of their Helper Buddy.

The overall goal of this project is to determine the feasibility of the FBI and evaluate its impact on physical and cognitive functions, as well as other measures of daily living among PwMS in a home-based environment. This protocol builds on strong evidence from previous successful trials involving neurological populations. It has been piloted in a laboratory setting with individuals with stroke and mild cognitive impairment, demonstrating both safety and efficacy. In addition, it has been tested in telerehabilitation formats among healthy older adults and frail older individuals, with results indicating feasibility, safety, and effectiveness for independent home exercise and no reported adverse events.

The investigators now intend to translate this evidence-based protocol to examine its effects in people with multiple sclerosis. If successful, this study could have substantial impact by providing a low-cost, safe, and effective intervention that increases accessibility for rural and underserved populations.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants assigned to the Functional Balance Intervention (FBI) will complete a 4 month, home based, multicomponent balance and cognitive motor training program. Sessions occur 2 days per week for 1 hour each and are performed independently at home with a designated helper buddy present for safety. Each session includes randomized blocks of functional agility, functional strength, dual task cognitive motor exercises, and vestibular training. Exercises emphasize dynamic balance, multi joint strength, postural control, attention, processing speed, and visuospatial orientation. Dual task components include custom computer based stepping games that integrate cognitive tasks with functional movements. Vestibular components include gaze stabilization, head turn walking, and figure of eight walking. Exercise difficulty progresses based on predefined home evaluation criteria. Participants receive a training manual, home equipment kit, weekly follow up via Zoom, and safety monitoring.

Treatment:

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

Stretching Group

Active Comparator group

Description:

Participants assigned to the stretching program will complete a 4 month, home based flexibility training regimen matched in duration and frequency to the intervention group. Sessions occur 2 days per week for 1 hour each and include progressive stretching of major upper limb, lower limb, core, and back muscle groups. All stretches are performed in standing to match upright time and positional demands of the Functional Balance Intervention. Each session begins with a brief warm up and concludes with a 10 minute cool down emphasizing relaxation and breathing exercises. Participants receive a printed exercise manual detailing weekly schedules, safety precautions, and instructions for each stretch. No specialized equipment or computer based components are required. A helper buddy must remain present during all sessions for safety. Participants also participate in weekly Zoom check ins to monitor adherence, address concerns, and review home safety recommendations.

Treatment:

Behavioral: Stretching