No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 – 90
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for people with multiple sclerosis who want to improve their physical and cognitive abilities. Participants will take part in a balance training program over four months, joining sessions online through Zoom.
Are You a Good Fit for This Trial?
Rules you outSevere cognitive impairmentGlobal aphasia
You may be able to join if
I am between 40 and 90 years old.
I have been diagnosed with multiple sclerosis.
I have been on stable disease-modifying therapy for at least 6 months.
I can stand up from a chair independently.
I speak English.
I am willing to participate in all study procedures.
I have reliable internet access.
I have a helper buddy available for all sessions.
You may not be able to join if
I have had an MS relapse in the past 3 months.
I had major surgery less than 6 months ago.
I experience shortness of breath at rest.
I have uncontrolled pain greater than 3 out of 10.
I have uncontrolled hypertension or diabetes.
I have a history of seizures in the past year.
I am currently receiving cognitive or physical rehabilitation.
I use a pacemaker.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 with…
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.
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