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Home Based Functional Balance Intervention for Multiple Sclerosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Training will occur twice weekly for four months."
  • "Participants will then engage in independent training sessions with their Helper Buddy twice per week for four months."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a home balance program against stretching for people ages 40–90 with multiple sclerosis (MS). It will look at movement, thinking, and daily life skills. Training is twice a week for four months, with a helper present and study checkups online.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 40–90 and report having MS. Have been on stable MS treatment for at least 6 months.
  • Have no balance-related physical or occupational therapy in the past 6 months.
  • Have moderate disability and mild thinking or memory problems, based on study tests.
  • Be inactive or only moderately active, based on a study survey.
  • Be able to stand from a chair without another person's help and walk one block, with or without a walking aid. Meet the study's walking and balance score limits.
  • Meet heart safety and language test limits. Have no other health condition that affects standing or walking.
  • Speak English, have reliable internet, and agree to all study tasks, including Zoom sessions.
  • Have a nearby helper age 18 or older for all sessions. The helper must speak English, use Zoom, and be healthy enough to help with safety, positioning, and communication.

Who can't join

  • An MS flare-up in the past 3 months, major surgery or a broken bone in the past 6 months, or a hospital stay in the past 3 months.
  • Shortness of breath at rest, uncontrolled pain above 3 out of 10, uncontrolled high blood pressure or diabetes, unsafe heart-related test results, or a pacemaker.
  • A history of epilepsy, uncontrolled seizures in the past year, or an injury to nerves outside the brain and spinal cord.
  • Severe thinking or memory problems, severe trouble using or understanding language, or currently receiving therapy for thinking skills or physical function.
  • Disability that limits daily activities, a balance test score below 40 out of 56, or inability to walk one block even with a walking aid.
  • Use of sedating drugs that may affect training, antidepressants, anxiety drugs, or drugs that change the course of Alzheimer's disease or dementia; or joining an Alzheimer's drug trial.
  • Moderate or high risk on the study's exercise safety survey.
  • Being pregnant, being in prison or another vulnerable group, not speaking English, or being under age 18.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

IL