Functional Balance Intervention for Multiple Sclerosis
(HomeFBIinMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new balance training program for people with multiple sclerosis (MS). The goal is to determine if this multicomponent balance intervention can improve physical abilities, thinking skills, and everyday activities more effectively than a usual stretching routine. Participants will either try the new balance exercises or continue with stretching, both performed at home with some assistance. It suits those with MS who can stand up from a chair independently and haven't recently undergone balance therapy. Sessions are virtual, so internet access and a buddy to assist are important. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily living for those with MS.
Will I have to stop taking my current medications?
The trial requires that participants have been on stable disease-modifying therapy for at least 6 months, but it excludes those using sedative medications, Alzheimer's/dementia-modifying drugs, antidepressants, or anxiety medications. If you are taking any of these, you may need to stop before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Functional Balance Intervention (FBI) for people with multiple sclerosis (MS) is under study to assess its effects on physical and mental abilities. Although detailed safety information from past studies is lacking, this early-phase trial tests the treatment's safety in humans.
This intervention is non-invasive, meaning it doesn't involve surgery or entering the body. It includes exercises focusing on balance, strength, and coordination, which are generally safe in other contexts. A "Helper Buddy" supports participants during sessions, emphasizing safety.
As a Phase 1 trial, the primary goal is to determine the intervention's practicality and safety. Participation contributes to understanding the safety and effectiveness of this balance intervention for people with MS.12345Why are researchers excited about this trial?
Researchers are excited about the Functional Balance Intervention for multiple sclerosis because it combines physical and cognitive training in a home-based program. Unlike traditional treatments that often focus solely on physical therapy or medication, this approach integrates strength, agility, and dual-task exercises with cognitive tasks, aiming to improve both physical balance and mental processing. The inclusion of computer-based stepping games and vestibular exercises, like gaze stabilization and head turn walking, is unique and may offer a more holistic improvement in balance and coordination. This innovative method could potentially enhance quality of life by addressing multiple aspects of motor and cognitive function simultaneously.
What evidence suggests that this trial's treatments could be effective for multiple sclerosis?
Research has shown that the Functional Balance Intervention (FBI), which participants in this trial may receive, can greatly improve balance and quality of life for people with multiple sclerosis (MS). One study found that virtual training programs like the FBI helped people balance better than traditional exercises. Another review of studies showed that balance-focused activities can reduce falls and improve stability in adults with MS. These findings suggest that the FBI could enhance physical and mental functions, as well as daily activities, for people with MS.12356
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
Citations
Functional Balance Intervention in Multiple Sclerosis
Hypothesis 1: After 4 months of training, the FBI will show significantly higher improvements in physical function compared to the stretching. Aim 2: Examine ...
Home Based Functional Balance Intervention for Multiple ...
Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the ...
Development of the Better Balance Program for People with ...
Systematic review: the effectiveness of interventions to reduce falls and improve balance in adults with multiple sclerosis. Arch Phys Med Rehabil. 2015;96 ...
Balance rehabilitation for patients with Multiple Sclerosis ...
The virtual training program significantly improved balance and quality of life in male MS patients compared to traditional exercises.
5.
trialx.com
trialx.com/clinical-trials/listings/302584/functional-balance-intervention-in-multiple-sclerosis/Functional Balance Intervention in Multiple Sclerosis
Hypothesis 1: After 4 months of training, the FBI will show significantly higher improvements in physical function compared to the stretching.
Home Based Functional Balance Intervention for Multiple ...
The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional ...
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