Functional Balance Intervention in Multiple Sclerosis
Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
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.
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.