Functional Balance Intervention in Multiple Sclerosis

NCT06341023 | Recruiting DMC

• 1 other identifier: 2023-1430
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Sclerosis

Keywords

Functional Balance; Cognition; Dual task; Physical function; Muscular strength; Spasticity; Sensorimotor dysfunction; Fall prevention; Vestibular

Outcome Measures

Primary Outcomes (7)

• Change in physical function

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in cognitive function

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in dual task balance performance

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in dual task gait performance

  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

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in measured community mobility

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in self-reported community mobility

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in self-reported quality of Life

  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.

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

Secondary Outcomes (4)

• Change in walking performance

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in walking speed

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in balance confidence

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

• Change in functional independence

  Week 3 (Pre-training Assessment), Week 21 (Post-training assessment)

Study Arms (4)

Lab-based FBI

EXPERIMENTAL

Participants in the lab-based functional balance intervention (FBI) group will receive 4 months of exercise training in the lab (2 times per week for 16 weeks, total 32 sessions). The exercise training will consist of multiple components including functional agility, functional strength, dual-tasking and vestibular exercises.

Behavioral: Functional Balance Intervention

Lab-based Stretching

ACTIVE COMPARATOR

Participants in the lab-based stretching group will receive 4 months of stretching in the lab (2 times per week for 16 weeks, total 32 sessions).The stretching program will include progressive stretches for upper and lower-limb muscles, core and back muscles followed by a cool-down of 10 mins including relaxation and breathing exercises. Stretching exercises will include single and multi-joint stretches designed to target improvements in performance of daily living activities.

Behavioral: Stretching

Home-based FBI

EXPERIMENTAL

Participants in the home-based functional balance intervention (FBI) group will be asked to complete 4 months of exercise training at home (2 times per week for 16 weeks, total 32 sessions). The exercise training will consist of multiple components including functional agility, functional strength, dual-tasking and vestibular exercises.

Behavioral: Functional Balance Intervention

Home-Based Stretching

ACTIVE COMPARATOR

Participants in the home-based stretching group will be asked to complete 4 months of stretching at home (2 times per week for 16 weeks, total 32 sessions).The stretching program will include progressive stretches for upper and lower-limb muscles, core and back muscles followed by a cool-down of 10 mins including relaxation and breathing exercises. Stretching exercises will include single and multi-joint stretches designed to target improvements in performance of daily living activities.

Behavioral: Stretching

Interventions

Functional Balance Intervention BEHAVIORAL

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.

Home-based FBI; Lab-based FBI

Stretching BEHAVIORAL

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.

Home-Based Stretching; Lab-based Stretching

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (5)

• Kannan L, Vora J, Bhatt T, Hughes SL. Cognitive-motor exergaming for reducing fall risk in people with chronic stroke: A randomized controlled trial. NeuroRehabilitation. 2019;44(4):493-510. doi: 10.3233/NRE-182683.

  PMID: 31256084 BACKGROUND

• Motl RW, Sandroff BM, Kwakkel G, Dalgas U, Feinstein A, Heesen C, Feys P, Thompson AJ. Exercise in patients with multiple sclerosis. Lancet Neurol. 2017 Oct;16(10):848-856. doi: 10.1016/S1474-4422(17)30281-8. Epub 2017 Sep 12.

  PMID: 28920890 BACKGROUND

• Motl RW, Sandroff BM. Benefits of Exercise Training in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2015 Sep;15(9):62. doi: 10.1007/s11910-015-0585-6.

  PMID: 26223831 BACKGROUND

• Sandroff BM, Klaren RE, Pilutti LA, Dlugonski D, Benedict RH, Motl RW. Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis. J Neurol. 2014 Feb;261(2):363-72. doi: 10.1007/s00415-013-7204-8. Epub 2013 Dec 10.

  PMID: 24323244 BACKGROUND

• Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.

  PMID: 16643953 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanvi Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudri Purohit, MS

CONTACT

312-413-9772; rpuroh2@uic.edu

Swaranka Deshmukh, MS

CONTACT

3123553988; sdeshm9@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to group existence and assignment and outcome assessors will be blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: January 21, 2025
• Primary Completion: January 9, 2026
• Study Completion (Estimated): January 9, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)