Functional Balance Intervention in Multiple Sclerosis - Trial NCT06341023

Timeline & Enrollment

Primary Outcome

Change in physical function,Change in cognitive function,Change in dual task balance performance,Change in dual task gait performance,Change in measured community mobility,Change in self-reported community mobility,Change in self-reported quality of Life

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.

ICD-10 Classifications