Functional Balance Intervention for Multiple Sclerosis (FBIinMS Trial)

Palo Alto (17 mi)

Overseen byTanvi Bhatt, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Illinois at Chicago

No Placebo Group

Trial Summary

What is the purpose of 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.

Eligibility Criteria

This trial is for people with Multiple Sclerosis (MS) who can participate in a study to improve their balance and cognitive functions. Participants will be screened over the phone, then in person, and must be able to commit to twice-weekly sessions for four months either at a lab or from home.

Treatment Details

The trial tests a Functional Balance Intervention (FBI), comparing it against simple stretching exercises. It's designed as two studies: one conducted in a lab and another that participants can do at home. Each participant is randomly assigned to either the FBI or stretching group.

4Treatment groups

Experimental Treatment

Active Control

Group I: Lab-based FBIExperimental Treatment1 Intervention

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.

Group II: Home-based FBIExperimental Treatment1 Intervention

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.

Group III: Home-Based StretchingActive Control1 Intervention

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.

Group IV: Lab-based StretchingActive Control1 Intervention

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.