RecruitingNot ApplicableNCT06341023

Functional Balance Intervention in Multiple Sclerosis

Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis

Sponsor

University of Illinois at Chicago

Enrollment

120 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a functional balance training program for adults with multiple sclerosis (MS) who have mobility or walking difficulties. Participants either attend in-person sessions or complete the program remotely, to see which approach better improves balance and walking. **You may be eligible if...** - You are 55 to 80 years old - You have a self-reported diagnosis of multiple sclerosis - You have been on stable MS medication (disease-modifying therapy) for at least 6 months - You have not had physical or occupational therapy in the past 6 months - You can stand up from a chair independently (with or without using armrests) - You have some degree of walking difficulty (based on an MS walking scale score between 25–75%) - You do not have any other major neurological, heart/lung, bone/joint, or systemic condition that affects standing and walking - You can understand and communicate in English - You have internet access (for the remote study option) **You may NOT be eligible if...** - You have another neurological condition (such as stroke or Parkinson's disease), serious cardiopulmonary disease, or major musculoskeletal injury besides MS - You are unable to commit to the 4-month training program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFunctional 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.

BEHAVIORALStretching

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.