Functional Balance Intervention for Multiple Sclerosis

(FBIinMS Trial)

Overseen By Swaranka Deshmukh, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Disease modifying therapy

Must not be taking: Sedatives, Alzheimer's drugs, Antidepressants

Disqualifiers: Recent MS relapse, Surgery, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 35

Duration: 16 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Functional Balance Intervention (FBI) can aid individuals with Multiple Sclerosis (MS) in enhancing their physical and cognitive abilities. The trial consists of two parts: one in a lab and the other at home, both comparing FBI to stretching exercises. Individuals with MS who have not received physical therapy for over six months and experience balance or cognitive challenges may be suitable candidates. Participants will engage in exercise sessions twice a week for four months to determine if these interventions can enhance daily life activities. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve the quality of life for those with MS.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on stable disease-modifying therapy for at least 6 months, so you should not stop taking these medications. However, you cannot participate if you are taking certain sedatives, Alzheimer's or dementia medications, anti-depressants, or anxiety drugs.

What prior data suggests that this Functional Balance Intervention is safe for people with Multiple Sclerosis?

Research shows that the Functional Balance Intervention (FBI) is safe and well-tolerated for people with multiple sclerosis (MS). Previous studies have found that similar balance training programs, which include exercises like agility and strength training, can be safely used by people with MS. These programs aim to improve balance and mobility by gradually increasing in difficulty, ensuring participants are not pushed too hard too quickly.

This method has also been successful in treating other neurological conditions and in older adults, indicating it is a low-risk option. Past studies have reported no significant negative effects, suggesting that participants generally respond well to the treatment. While specific information on side effects for this intervention is limited, the lack of reported issues in similar programs is reassuring.

The trial is in its early stages, focusing on the treatment's safety and effectiveness. Although this means less detailed data might be available, the use of FBI in other situations provides some confidence in its safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Functional Balance Intervention (FBI) for multiple sclerosis (MS) because it offers a fresh approach focused on enhancing physical agility and strength through home-based or lab-based exercises. Unlike typical treatments that often rely on medications like interferons and immunosuppressants to manage symptoms, the FBI emphasizes a holistic exercise regimen. This approach includes functional agility, dual-tasking, and vestibular exercises, which aim to improve balance and daily living activities. By potentially enhancing physical function and quality of life without the side effects of medication, this intervention could offer a significant advantage for those living with MS.

What evidence suggests that this trial's Functional Balance Intervention could be effective for multiple sclerosis?

Research has shown that Functional Balance Interventions (FBI) can help people with multiple sclerosis (MS) improve their physical abilities. In this trial, participants will join different arms to evaluate the effectiveness of FBI. Studies indicate that balance training with challenging tasks enhances movement and stability. Various studies have found a moderate improvement in balance and mobility, with a measured effect size of 0.46. While FBI might not significantly impact cognitive skills, it effectively boosts physical function. FBI includes exercises like agility, strength, and dual-tasking, which contribute to these positive results. Overall, FBI appears promising for improving physical symptoms in MS. ^{1 3 4 6 7}

Who Is on the Research Team?

Tanvi Bhatt, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Telephone screening: Must have access to the internet and must be willing to attend weekly zoom calls and undergo monthly tests on zoom (for Study 2 participants only)

I have been on a stable treatment for my condition for at least 6 months.

I can stand up from a chair by myself, with or without using handrails.

Exclusion Criteria

Telephone screening: Uncontrolled/untreated hypertension or diabetes

In-person screening: Cardiovascular abnormalities

I am taking medication for Alzheimer's or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person), phone screening

Pre-training Assessment

Participants undergo pre-training assessment and randomization into FBI or Stretching groups

2 weeks

1 visit (in-person)

Treatment

Participants receive either Functional Balance Intervention or Stretching for 4 months

16 weeks

32 sessions (2 times per week)

Post-training Assessment

Participants are assessed for changes in physical and cognitive function after training

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Balance Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Lab-based FBI Experimental Treatment 1 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 FBI Experimental Treatment 1 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 Stretching Active Control 1 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 Stretching Active Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06341023

Functional Balance Intervention in Multiple Sclerosis Interventions like aerobic and/or strength training are effective in improving physical function, yet effects on cognitive dysfunction might not be very robust.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06341023/functional-balance-intervention-in-multiple-sclerosis

Functional Balance Intervention in Multiple Sclerosis This project involves two sub-parts: Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015930/

A highly challenging balance training intervention for people ... Balance training interventions with a gradual progression of difficulty and highly challenging tasks designed specifically for people with multiple sclerosis ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211034822009282

Mobility and balance rehabilitation in multiple sclerosis Twenty-nine studies (40.8%) had the balance outcome as the primary outcome, while 42 studies (59.1%) had balance as secondary outcome or did not specify primary ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11490070/

Effects of Balance Exercise Interventions on ... - PubMed Central Interventions evaluated with a balance composite score or a mobility test showed a moderate effect size (ES = 0.46 [95% confidence interval (CI) ...

6. trialx.com trialx.com/clinical-trials/listings/302584/functional-balance-intervention-in-multiple-sclerosis/

Functional Balance Intervention in Multiple Sclerosis This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12374876/

Functional exercise training in persons with multiple sclerosis This review aims to provide a comprehensive overview of the existing literature on the effects of functional exercise training on functional ...