Actively Recruiting
Functional Balance Intervention in Multiple Sclerosis
Led by University of Illinois at Chicago · Updated on 2025-03-12
120
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project involves two sub-parts: Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis. Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis. Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas.
CONDITIONS
Official Title
Functional Balance Intervention in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 80 years
- Self-reported diagnosis of Multiple Sclerosis
- On stable disease modifying therapy for at least 6 months
- No physical or occupational therapy received in past 6 months
- Able to stand up from a chair independently, with or without handrails
- Score between 25-75% on 12-item Multiple Sclerosis walking scale indicating mobility disability
- No other acute or chronic neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing or walking
- Able to understand and communicate in English
- Willing to complete all study aspects including assessments, 4-month training, and accelerometer use
- Positive response to memory or thinking decline question marks mild cognitive impairment
- For Study 1: Willing to attend lab sessions twice weekly for 4 months
- For Study 2: Must have internet access, willing to attend weekly Zoom calls and monthly online tests
- For Study 2: Living with a family member
- For Study 2: Have a helper buddy present during home exercise and monthly Zoom evaluations
- Mobility disability with Expanded Disability Status Scale score between 4.0-6.5
- Mild cognitive impairment with Montreal Cognitive Assessment score 18-25 and specific neuropsychological criteria
- Physically inactive with Godin leisure time questionnaire score less than 14
You will not qualify if you...
- MS relapse or exacerbation within last 3 months
- Recent major surgery within 6 months or hospitalization within 3 months interfering with testing or training
- Shortness of breath or uncontrolled pain above 3/10 at rest
- Uncontrolled or untreated hypertension or diabetes
- Bone fracture within the last 6 months
- Disability in performing daily living activities
- Diagnosis of epilepsy or uncontrolled seizures in past year
- Use of sedative drugs that interfere with testing or training
- Use of Alzheimer's or dementia modifying medications or participation in related drug trials
- Use of anti-depressants or anxiety medications
- Moderate or high risk of injury or death with strenuous exercise based on Physical Activity Readiness Questionnaire
- Severe cognitive impairment indicated by Telephone Interview for Cognitive Status score 18 or higher
- Currently undergoing cognitive or physical rehabilitation
- Pacemaker users
- Cardiovascular abnormalities including high heart rate or blood pressure outside specified ranges during rest
- Osteopenia with T-score less than or equal to -2.5 on heel ultrasound
- Loss of protective peripheral sensation
- Global aphasia indicated by low score on Mississippi Aphasia Scoring test
- Peripheral nerve injuries
- For Study 2: High fall-risk with Berg Balance Scale score below 40
- For Study 2: Inability to walk one block with or without assistive device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Rudri Purohit, MS
CONTACT
S
Swaranka Deshmukh, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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