NCT06341023 · University of Illinois at Chicago
Functional Balance Intervention in Multiple Sclerosis
(FBIinMS)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Functional Balance Intervention
Participants in the intervention group will undergo a multi-component FBI exercise program, both in a lab setting (Study 1) and at home (Study 2), for 2 days/week over 4 months. This evidence-based protocol, previously piloted with chronic stroke patients, older adults with mild cognitive impairment, and pre-frail older adults, focuses on improving physical (endurance, strength, balance, and gait) and cognitive function (processing speed, attention, and memory). The program consists of functional agility, functional strength, dual-task, and vestibular exercises, with each 1-hour session including 10 minutes dedicated to each component. The exercise order will be randomized for each session, preceded by a warm-up with gentle self-stretching exercises.
BEHAVIORAL
Stretching
Participants in the control group will undergo a 4-month lab-based stretching program, with the same frequency and session length as the intervention group (1 hour/session for 2 days/week). The stretching regimen will include progressive stretches targeting upper and lower-limb muscles, core, and back muscles, followed by a 10-minute cool-down comprising relaxation and breathing exercises. These stretches are designed to improve performance in daily living activities. In Study 2, stretching participants will receive a detailed printed exercise manual for home-based training, ensuring consistency with the lab-based program. No additional equipment, such as computers or tablets, is required for the home stretching program.
Primary outcome measures
Change in physical function
Time frame: Week 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 function
Time frame: Week 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 performance
Time frame: Week 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 performance
Time frame: Week 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 mobility
Time frame: Week 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 mobility
Time frame: Week 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 Life
Time frame: Week 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations