Motor Learning for Multiple Sclerosis

(STRES-MS Trial)

Overseen By Feng Yang, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Psychiatric, Neurological, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether people with multiple sclerosis (MS) can learn motor skills from specific training designed to handle unexpected movements, such as slips and trips. The goal is to determine if this training, known as Perturbation Training, can help prevent falls in people with MS. Participants in the training group will walk on a treadmill with short, surprising disturbances, while the control group will walk without them. Individuals diagnosed with MS who can walk independently for at least 25 feet and have not previously undergone this type of training may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve balance and safety for people with MS.

Do I need to stop 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 or your doctor.

What prior data suggests that perturbation training is safe for people with multiple sclerosis?

Research shows that the type of training under investigation, called perturbation training, is generally safe for people with multiple sclerosis (MS). Studies have found that this training can improve balance and walking without causing major side effects. For instance, one study showed that participants had better balance after the training and did not experience any significant negative effects. Another smaller study also reported positive results for preventing falls, with no serious side effects.

During perturbation training, participants wear a safety harness to prevent injuries from unexpected slips or trips. Overall, the safety data indicates that this treatment is well-tolerated, with minimal risks managed through safety measures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about perturbation training for multiple sclerosis because it offers a fresh approach to improving balance and motor skills. Unlike standard treatments that often involve medication or physical therapy exercises, perturbation training uses unexpected slips and trips to challenge and enhance patients' motor learning abilities. This innovative technique could potentially lead to better long-term retention of motor skills, providing a new avenue for managing symptoms and improving quality of life for people with multiple sclerosis.

What evidence suggests that perturbation training is effective for motor learning in multiple sclerosis?

Research has shown that perturbation training, which participants in this trial may receive, can help people with multiple sclerosis (MS) improve balance and reduce falls. Studies have found that this training enhances the ability to react quickly and regain balance after slipping. In one study, people with MS demonstrated immediate and lasting improvements in stepping and balancing after just two weeks of training. Another study found that perturbation training significantly reduces both the risk and frequency of falls in people with MS. Overall, this training can lead to better balance, walking, and stability, which are crucial for reducing the fear of falling and improving daily movement. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for ambulatory individuals with Multiple Sclerosis (MS) who can walk and are interested in learning fall-resistant skills. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Montreal Cognitive Assessment score of 23 or higher

I can stand on my own for at least 30 seconds.

Free from pregnancy

Exclusion Criteria

I do not have severe psychiatric, neurological, or heart conditions.

My condition worsened in the last 8 weeks.

Previous experience with perturbation training

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acquisition Session

Participants undergo initial training with perturbation or control walking on a treadmill, followed by an unexpected slip and trip overground

1 session

1 visit (in-person)

Retention Sessions

Participants experience treadmill and overground slip and trip perturbations at 3-month and 6-month intervals

6 months

2 visits (in-person)

Follow-up

Participants are monitored for real-life falls and near falls through weekly online surveys

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Perturbation Training

Trial Overview The study tests if people with MS can improve their balance and reduce falls by learning motor skills through repeated slip or trip exposures. Participants will undergo perturbation training and treadmill walking to assess their motor learning capacity.

How Is the Trial Designed?

Group I: Training Group Experimental Treatment 1 Intervention

During the acquisition session, this group will undergo perturbation training on the treadmill while wearing a safety harness. Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground. During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.

Group II: Control Group Active Control 1 Intervention

During the acquisition session, this group will walk on the treadmill without perturbations for the same amount of time as the training group. Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground. During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36322558/

Perturbation-based Balance Training to improve postural ... The results show that PBT is at least as effective as CBT in improving balance and decreasing falls, while it has superiority over CBT.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034819300549

Protective stepping in multiple sclerosis: Impacts of a single ... A meta-analysis of randomized controlled trials indicated that perturbation-based training (PBT) significantly decreases risk and rate of falling in normal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034824005078

The effects of a 2-week in-place reactive balance training ... PwMS exhibited immediate and retained improvements in reactive stepping after 2-weeks of perturbation training.

4. bezmialemscience.org bezmialemscience.org/pdf/bd1986e1-0bc1-4f4d-af66-3a184850a065/articles/bas.galenos.2021.5243/BezmialemScience-10-10-En.pdf

Effects of Perturbation Training on Balance, Walking, and ... Investigating the effect of PT on balance, walking, lumbar stabilization, and fear of falling is effective in long-term MS. Perturbations are known to improve ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6107338/

Effects of External Perturbations on Anticipatory and ... The inability to produce efficient APAs and CPAs during perturbations may explain the high rates of postural instability and falls in patients with MS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11039920/

Effects of exercise in people with multiple sclerosis Exercise had beneficial effects in improving balance, walking ability, walking endurance, fatigue, and quality of life in people with MS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10119738/

Effect of Treadmill Perturbation-Based Balance Training on ... Results of this trial showed that participants who received an 80-minute PBT intervention experienced a statistically nonsignificant 22% ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003321002412

Reactive balance responses to a trip and slip during gait in ... Following trips, participants with MS had significantly delayed response initiation, lower toe clearance, shorter step length, and greater trunk sway (P < 0.05) ...

9. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2022.1015394/full

Perturbation-based balance training: Principles ... More recently, a large, pragmatic RCT conducted in a clinical setting (34) and a smaller experimental trial (35) also reported positive fall-related outcomes.