Functional Balance Intervention in Multiple Sclerosis

Recruiting now · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06341023

Run by

University of Illinois at Chicago

People needed

120

Starts

2025-01-21

Expected to finish

2027-07-09

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Telephone screening (for Study 1 and 2):
• Age group: Adults between 55-80 years of age
• Self-reported diagnosis of Multiple Sclerosis
• Be on stable disease modifying therapy (DMT) for ≥6 months.
• Has not received physical therapy or occupational therapy services for ≥6 months.
• Able to stand up from a chair independently with or without use of handrails.
• Score between 25-75% on the 12-item Multiple Sclerosis walking scale, which indicates that they have mobility disability or walking dysfunction.
• Absence of any other acute or chronic neurological (Stroke, Parkinson's disease), cardiopulmonary, musculoskeletal (injuries like fractures or dislocations or pathologies like Rheumatoid arthritis) or systemic diagnosis, all conditions that except Multiple Sclerosis that can directly impact individual's ability to stand and walk.
• Can understand and communicate in English because the protocol will only be delivered in English.
• Be willing to complete all aspects of the study protocol (outcome assessments, 4-month training, accelerometer wear, etc.).
• Individuals who give a positive response (Yes) to the question of whether the participants feel that their memory or thinking skills worsened lately?" will be marked as potential individuals with mild cognitive impairment.
• Must be willing to come to the lab for 2 times a week for four months for training sessions (for Study 1 participants only).
• Must have access to the internet and must be willing to attend weekly zoom calls and undergo monthly tests on zoom (for Study 2 participants only).
• Must be living with a family member (for Study 2 participants only).
• Must have a helper buddy to be present during the home exercise sessions and monthly progression evaluation Zoom calls with the researcher (for Study 2 participants only).
• In-person Screening (for Study 1 and 2):
• Must have mobility Disability, a score of 4.0-6.5 on the Expanded Disability Status Scale (EDSS).
• Must have mild cognitive impairment, a score of 18-25 on the Montreal Cognitive Assessment (MoCA) and score >1 but less than 2.5 standard deviations on 2 or more measures within at least 1 domain (e.g., memory, language, attention/processing speed, executive function, visuospatial abilities) on the established criteria named "Jak / Bondi" criteria.
• Must be physically inactive, a score <14 on the questionnaire named "Godin leisure time" questionnaire.

You may not qualify if…

• Telephone Screening (for Study 1 and 2):
• MS Relapse or exacerbation ≤3 months
• Recent major surgery (< 6 months) or hospitalization (< 3 months) that might interfere with testing/training.
• Complaints of shortness of breath or uncontrolled pain (>3/10 on visual analogue scale (VAS)) at rest to avoid complications/injuries during testing/training.
• Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications during testing/training.
• Self-reported history of bone fracture in the last six months to avoid complications/injuries during testing/training.
• Self-reported disability in performing activities of daily living (with or without assistive device).
• Self-reported diagnosis of epilepsy or uncontrolled seizures in the past year.
• Intake of sedative drugs (diazepam, lorazepam, midazolam, propofol, dexmedetomidine, thiopental) that might interfere with testing/training.
• Intake of any Alzheimer's Disease (AD) or dementia modifying medications (donepezil, rivastigmine, galantamine, aducanumab) as well as other anticipated FDA approved drugs that may be approved during the next 5 years. Individuals who are enrolled in any AD disease modifying drugs trials that might interfere with testing/training or affect the ability to understand instructions will also be excluded.
• Intake of anti-depressants or anxiety drugs.
• Moderate or high risk for possible injury or death when undertaking strenuous or maximal exercise as indicated by reporting a 'YES' on any of the seven items on the Physical Activity Readiness Questionnaire. These participants will be excluded from participation, and further advised to seek medical guidance from their physician.
• People with severe cognitive impairment will be excluded, indicated by a score of 18 or higher on the Telephone Interview for Cognitive status (TICS-M). These participants will be advised to seek medical guidance from the physician.
• Currently undergoing any cognitive rehabilitation for higher brain functions or physical rehabilitation.
• Pacemaker users
• In-person Screening (for Study 1 and 2):
• Cardiovascular abnormalities: Heart Rate > 85% of age-predicted maximal heart rate, systolic blood pressure (SBP) > 165 millimetre of mercury (mmHg), diastolic blood pressure > 110 mmHg during rest OR systolic blood pressure < 90 mmHg and/or mean arterial blood pressure < 65 mmHg OR oxygen saturation < 95% during rest.
• Osteopenia (a T - Score of ≤-2.5 on heel ultrasound). Participants with a score ≤ -2.5 will be advised to seek medical guidance from their physician.
• Loss of protective peripheral sensations (inability to perceive 5.07/10 g on the Semmes Monofilament testing).
• Global aphasia (A score of <71% on the Mississippi Aphasia Scoring test)
• Peripheral nerve injuries (traumatic nerve lacerations, pathological nerve damage).
• High fall-risk, <40/56 on Berg Balance Scale (for Study 2 participants only)
• Inability to walk 1 block with or without an assistive device (for Study 2 participants only)

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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