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Behavioural Intervention

Home-based FBI for Multiple Sclerosis (FBIinMS Trial)

N/A
Waitlist Available
Led By Tanvi Bhatt, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3 (pre-training assessment), week 21 (post-training assessment)
Awards & highlights

FBIinMS Trial Summary

This trial involves two parts:Study 1: Testing a lab-based program called Functional Balance Intervention (FBI) on physical and cognitive symptoms in people with Multiple Sclerosis (MS).Study 2

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves physical activity, potential side effects may include muscle soreness, fatigue, or injury related to exercise. The risk of serious side effects is likely low but depends on individual health conditions.

FBIinMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 (pre-training assessment), week 21 (post-training assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 (pre-training assessment), week 21 (post-training assessment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cognitive function
Change in dual task balance performance
Change in dual task gait performance
+4 more
Secondary outcome measures
Change in balance confidence
Change in functional independence
Change in walking performance
+1 more

FBIinMS Trial Design

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: 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.
Group IV: 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.

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Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,235 Total Patients Enrolled
13 Trials studying Multiple Sclerosis
1,586 Patients Enrolled for Multiple Sclerosis
Tanvi Bhatt, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
5 Previous Clinical Trials
468 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to enroll in this study at the moment?

"As per details on clinicaltrials.gov, recruitment for this particular clinical trial is currently inactive. The study was first listed on April 14th, 2024 and last modified on March 26th, 2024. Despite the lack of active recruitment for this trial, there are presently 544 other trials actively seeking participants."

Answered by AI

What are the primary objectives of this clinical trial?

"Additional secondary objectives comprise modifications in walking speed gauged through the Timed 25-Foot Walk test which evaluates"

Answered by AI

Is there a consideration for inclusion of participants aged above 80 years in this research trial?

"This research study is seeking individuals above 18 years of age but below the age of 90 to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Functional Balance Intervention in Multiple Sclerosis
Tanvi Bhatt 2024. "Functional Balance Intervention in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06341023.
~80 spots leftby Jan 2026
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