Back to search results

Functional Balance Intervention for Multiple Sclerosis

This study is looking at how a Functional Balance Intervention (FBI) can help people with Multiple Sclerosis (MS) improve their physical and thinking abilities. The FBI is an exercise program that has been tested before in other groups. You would either participate in this FBI program, which involves exercises in a lab or at home, or a stretching program. Researchers want to see if the FBI helps with physical function, thinking skills, and balance when doing two things at once. They are looking for adults aged 55-80 with MS who have been on stable medication for at least 6 months and can stand up from a chair on their own. The study is currently recruiting 120 participants.

Study design
This is a randomized controlled clinical trial with two groups of participants. There will be 120 participants in total, split between two studies.
What's involved
If you join, you would participate in either the Functional Balance Intervention or a stretching program for 2 days a week over 4 months. Assessments will be done at Week 3 (before training) and Week 21 (after training).
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at Week 3 (Pre-training Assessment) and Week 21 (Post-training assessment).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06341023

Functional Balance Intervention in Multiple Sclerosis

Recruiting
NAAges 18–90InterventionalTreatment
University of Illinois at Chicago
~120 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Functional Balance InterventionStretching

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in physical function
Measured over Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)
+6 more outcomes measured

Conditions

Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Tanvi Bhatt, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Rudri Purohit, MS
[email protected]
312-413-9772
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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).
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.

Exclusion

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
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)

What this trial measures

  • Change in physical functionWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    Physical function will be assessed via the Short Physical Performance Battery (SPPB). This batter includes tests for standing balance and muscle strength and is widely used among older adults and people with multiple sclerosis. Higher scores indicate better performance.

  • Change in cognitive functionWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    Cognitive function will be assessed by the Brief International Cognitive Assessment (BICAMS) The BICAMS is widely used in people with MS and consists of 3 sub-tests including the Symbols Digit Modalities test for assessing processing speed, the California Verbal Learning Test-II for assessing verbal learning and memory and the Brief Visuospatial Memory also for assessing learning and memory as a part of the BICAMS. All these tests are paper pencil questionnaires to assess different domains of cognitive function. Higher scores indicate better performance.

  • Change in dual task balance performanceWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    Dual task balance performance will be assessed via the limits of Stability with the letter number sequencing test. The Limits of Stability test assesses balance on a computerized balance system, which requires participants to shift weight without losing balance. Maximum excursion will be the outcome assessed using the Limits of Stability test. The Letter Number Sequencing test will be performed simultaneously. This test includes cognitive task involving generating alternating number-letter sequences. The accuracy and total responses will be the outcome measures recorded via this test. Higher values for accuracy and responses indicate better performance.

  • Change in dual task gait performanceWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    Dual task gait performance will be assessed via the Timed-up and Go test with the letter number sequencing test. The Timed-up and Go test evaluates functional mobility among individuals with multiple sclerosis. Participants will be asked to stand from a chair, walk 3 meters, and sit back. Lesser time to complete indicates better performance. The Letter Number Sequencing test will be performed simultaneously. This test includes cognitive task involves generating alternating number-letter sequences. The accuracy and total responses will be the outcome measures recorded via this test. Higher values for accuracy and responses indicate better performance

  • Change in measured community mobilityWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    The investigators will use the ActiGraph sensor to assess change in measured community mobility. Participants will be asked to wear the accelerometer device for the following 7 days for at least 12 hours per day. Participants will be asked to always wear the watch except during bathing, charging it, and sleeping. All of these are reliable and sensitive measures for assessing community mobility among people with multiple sclerosis. Greater number of steps per day indicate greater community mobility.

  • Change in self-reported community mobilityWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    The University of Alabama at Birmingham (UAB) has established a paper pencil questionnaire named "Lifespace Scale Questionnaire" will be used to assess change in self-reported community mobility. The Lifespace scale questionnaire measures a person's mobility in five areas: outside the bedroom, outside the house, in the neighborhood, outside of the neighborhood but in town, and outside town during the past four weeks. Higher scores indicate greater community mobility.

  • Change in self-reported quality of LifeWeek 3 (Pre-training Assessment), Week 21 (Post-training assessment)

    This will be assessed using the MS Impact Scale (MSIS-29), a self-reported measure that includes both physical (20 items) and psychological (9 items) aspects of life quality. Higher scores indicate better quality of life.