Torso Weighting for Multiple Sclerosis

(BBTW-MS Trial)

Overseen By Evan Pucillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of St. Augustine for Health Sciences

Disqualifiers: Concurrent neurological disorder, others

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called Balance-Based Torso-Weighting (BBTW) to help people with multiple sclerosis (MS) improve balance and stability. Researchers aim to determine how placing small weights on the body affects muscle activity and balance through special tests. The trial includes two groups: one with people who have MS and one with healthy participants. It may suit people with MS who can walk 20 meters without stopping, with or without a walking aid. As an unphased trial, this study allows participants to contribute to innovative research that could enhance balance and stability for those with MS.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that Balance-Based Torso-Weighting is safe for improving balance in people with multiple sclerosis?

Research shows that Balance-Based Torso-Weighting (BBTW) is generally safe for people with multiple sclerosis (MS). Studies have found that using BBTW can improve movement, such as walking faster and balancing better, without causing major side effects. For instance, one study found that people with MS who used BBTW walked faster and balanced on one leg for longer. These improvements suggest the treatment is safe.

Another study found that BBTW helped people with MS stay more stable and reduced their number of falls. Participants reported better standing and movement without major safety issues. Although the exact mechanisms behind these improvements remain unclear, the treatment itself has not shown harmful effects in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Balance-Based Torso-Weighting for multiple sclerosis because it offers a novel approach to improving balance and mobility, which are significant challenges for individuals with this condition. Unlike traditional treatments that often focus on medication to manage symptoms, this technique directly addresses the physical aspect by strategically adding weights to the torso. This method may enhance stability and reduce the risk of falls, potentially improving the quality of life for people with multiple sclerosis. By focusing on physical balance, this approach has the potential to complement existing therapies and offer a new avenue for managing the condition.

What evidence suggests that Balance-Based Torso-Weighting is effective for improving balance in multiple sclerosis?

Research shows that Balance-Based Torso-Weighting (BBTW) can help people with multiple sclerosis (MS) improve their balance and mobility. One study found that participants using BBTW walked 25 feet and completed the Timed Up and Go (TUG) test faster than those not using the weights. Another study found that 57% of people with MS improved their balance scores by at least 8 points after using BBTW. Additionally, BBTW has been linked to better walking patterns and overall function in people with MS. This trial will evaluate BBTW in two groups: one with MS and a healthy control group, both with and without the weighting. These findings suggest that BBTW might improve stability and reduce the risk of falls in people with MS. ^{2 3 4 6 7}

Who Is on the Research Team?

Amie Marie F Jasper, DPT, PhD

Principal Investigator

USAHS

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis (MS) or Systemic Sclerosis. It aims to explore how torso weighting affects muscle activation during balance tests. Participants should be able to perform balance tests and have no conditions that would interfere with the study.

Inclusion Criteria

* self-reported diagnosis of multiple sclerosis (MS)

* able to communicate in English

* able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Initial measurements of muscle activation and postural sway using EMG and force plates

1 day

1 visit (in-person)

Intervention

Participants undergo balance tests with and without balance-based torso weighting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Balance-Based Torso-Weighting

Trial Overview The study is testing Balance-Based Torso-Weighting (BBTW), a method where weights are placed on the torso to potentially improve balance. The immediate effects on muscle activity and stability will be measured using special equipment in people with MS and without.

How Is the Trial Designed?

Group I: Multiple Sclerosis Arm Experimental Treatment 1 Intervention

Without and with balance-based torso weighting

Group II: Healthy Control Arm Active Control 1 Intervention

Without and with balance-based torso weighting

Who Is Running the Clinical Trial?

University of St. Augustine for Health Sciences

Lead Sponsor

Trials

8

Recruited

450+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19470807/

Randomized clinical trial of balance-based torso weighting ... Results: People with BBTW showed a significant improvement in the 25-foot walk (P = .01) over those with no weight, and the TUG (P = .01) over those with ...

2. ijmsc.org ijmsc.org/view/effects-of-torso-weighting-on-standing-balance-and-falls-during-the-sensory-organization-test-in-people-with-multiple-sclerosis

Effects of Torso-Weighting on Standing Balance and Falls ... In the present study, 34 people with MS (57%) and three controls (30%) increased their composite score by at least 8 points. Because no MDC has ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06981013

Effects of Torso Weighting on Muscle Activation During ... BBTW has been found to improve the upright mobility of people with multiple sclerosis, however the mechanism underlying the improvement of balance and gait is ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999309000756

Balance-Based Torso-Weighting May Enhance ... Improvements in balance and function were noted when balance-based torso-weighting was applied to a small group of people with MS. The results of our study ...

5. neurology.org neurology.org/doi/10.1212/WNL.84.14_supplement.S28.003

Balance-Based Torso-Weighting Results In Fall Reduction ... BACKGROUND: PwMS fall frequently. BBTW has demonstrated improvement in gait characteristics and function in PWMS. Effect on falls was unknown.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4265579/

Gait Changes with Balance-Based Torso-Weighting in People ... Averaged gait trials showed that, with BBTW, PwMS had significantly increased velocity (p=.002), cadence (p=.007), and time spent in single-limb support (p=.014) ...

7. nationalmssociety.org nationalmssociety.org/news-and-magazine/momentum-magazine/research-and-science/weight-training

Weight Training: Vest for MS Balance Increase in Gait Speed ... In a smaller study in 2015, Allen and collaborators showed that gait speed increased with balance-based torso-weighting ...