Functional Balance Intervention for Multiple Sclerosis
(HomeFBIinMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS).
Combined Specific Aims:
Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group).
Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group.
Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program.
Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group.
Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life).
Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group.
All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy.
The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.
Are You a Good Fit for This Trial?
This trial is for people aged 40-90 with Multiple Sclerosis, stable on therapy for at least 6 months, and not in balance-related PT/OT recently. They must be able to stand from a chair, score 25-75% on the MS Walking Scale, have no other major health issues affecting mobility, speak English, are willing to do Zoom sessions and have internet access.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-training Assessment
Participants complete a pre-training assessment session before randomization
Treatment
Participants engage in either the Functional Balance Intervention or a stretching program for 4 months
Post-training Assessment
Participants complete post-training assessments to evaluate changes in physical and cognitive functions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Multicomponent balance intervention
Trial Overview
The study tests a Functional Balance Intervention (FBI) involving dual-tasking, strength training, vestibular and dynamic balance exercises against a control group doing stretching. It's designed to see if FBI improves physical/cognitive functions and daily living activities over four months via virtual assessments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants assigned to the Functional Balance Intervention (FBI) will complete a 4 month, home based, multicomponent balance and cognitive motor training program. Sessions occur 2 days per week for 1 hour each and are performed independently at home with a designated helper buddy present for safety. Each session includes randomized blocks of functional agility, functional strength, dual task cognitive motor exercises, and vestibular training. Exercises emphasize dynamic balance, multi joint strength, postural control, attention, processing speed, and visuospatial orientation. Dual task components include custom computer based stepping games that integrate cognitive tasks with functional movements. Vestibular components include gaze stabilization, head turn walking, and figure of eight walking. Exercise difficulty progresses based on predefined home evaluation criteria. Participants receive a training manual, home equipment kit, weekly follow up via Zoom, and safety monitoring.
Participants assigned to the stretching program will complete a 4 month, home based flexibility training regimen matched in duration and frequency to the intervention group. Sessions occur 2 days per week for 1 hour each and include progressive stretching of major upper limb, lower limb, core, and back muscle groups. All stretches are performed in standing to match upright time and positional demands of the Functional Balance Intervention. Each session begins with a brief warm up and concludes with a 10 minute cool down emphasizing relaxation and breathing exercises. Participants receive a printed exercise manual detailing weekly schedules, safety precautions, and instructions for each stretch. No specialized equipment or computer based components are required. A helper buddy must remain present during all sessions for safety. Participants also participate in weekly Zoom check ins to monitor adherence, address concerns, and review home safety recommendations.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
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