86 Participants Needed

Perturbation Training for Stroke

CJ
Overseen ByCamden Jacobs
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have had a stroke and are at risk of falling, significantly affecting their daily lives. It tests two methods to improve balance while walking: responding to sudden changes (Reactive Perturbations) and anticipating them (Proactive Perturbations). The trial seeks participants who had a stroke over six months ago, have fallen or fear falling, and can walk on a treadmill without support. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance balance and reduce fall risk for stroke survivors.

Will I have to stop taking my current medications?

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 these perturbation methods are safe for improving post-stroke walking balance?

Research has shown that perturbation-based balance training (PBT) can help stroke patients improve their balance and ability to walk. This training involves controlled movements that challenge balance, potentially preventing falls. Some studies found that PBT reduced fall rates in daily life by up to 52%. However, the quality of the evidence is often low, so more research is needed to confirm these findings.

Both proactive and reactive techniques in PBT offer similar benefits, improving balance and walking, especially for those with severe balance issues. While the evidence is promising, not all studies have shown strong proof that these methods reduce falls. The training is generally well-tolerated, with no major safety concerns reported.

In summary, both proactive and reactive PBT techniques appear safe for stroke patients and may help reduce falls and improve balance.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to stroke rehabilitation through perturbation training. Unlike traditional therapies that primarily focus on restoring movement through repetitive exercises, this trial involves two innovative methods: Proactive and Reactive Perturbations. These techniques are designed to challenge and improve balance and coordination by simulating real-life disruptions, potentially leading to quicker and more effective recovery. By targeting the body's ability to adapt to unexpected changes, this approach could offer a significant advantage over standard physical therapy, potentially speeding up recovery times and improving overall outcomes for stroke patients.

What evidence suggests that these perturbation methods could be effective for improving post-stroke walking balance?

Research shows that a type of balance training called perturbation training may help improve balance in people who have had a stroke. In this trial, participants will be assigned to either proactive or reactive perturbation training. Studies have found that proactive perturbation training can greatly improve balance and walking ability, especially for those with serious balance problems. However, it doesn't significantly boost confidence in balancing, and the quality of the evidence is low. Participants in the reactive perturbations arm have shown improved control over quick steps needed to prevent falls. More reactive exercises are linked to better balance recovery. Overall, both training methods seem promising for improving balance after a stroke, but more research is needed to confirm their effectiveness in everyday life.12678

Who Is on the Research Team?

JD

Jesse Dean

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke at least 6 months ago, have experienced falls or fear falling, can walk on a treadmill without support, and have a walking speed of at least 0.2 meters per second. It's not suitable for those with certain heart conditions, other neurological disorders or dementia, severe lower limb orthopedic issues, cerebellar damage, extremely high blood pressure, significant visual impairments, recent DVT/pulmonary embolism events or uncontrolled diabetes.

Inclusion Criteria

I had a stroke more than 6 months ago.
I can walk at a speed of at least 0.2 meters per second.
I can walk on a treadmill without needing a cane or walker.
See 2 more

Exclusion Criteria

I have a history of serious heart conditions.
I have a leg or foot condition that affects how I walk.
I am legally blind or have severe trouble seeing.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo perturbation training to improve post-stroke walking balance and reduce fall incidence

8 weeks
Regular in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Monitoring through 2-week calendars

What Are the Treatments Tested in This Trial?

Interventions

  • Proactive Perturbations
  • Reactive Perturbations
Trial Overview The study examines two types of mechanical perturbations during walking—proactive and reactive—to see if they improve balance and reduce the risk of falls in post-stroke patients. Participants will be subjected to these perturbations while walking to assess their effectiveness in enhancing stability.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Reactive PerturbationsExperimental Treatment1 Intervention
Group II: Proactive PerturbationsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

Perturbation-based balance training (PBT) has shown significant reductions in falls incidence among healthy older adults and certain high-risk groups, such as those with Parkinson's disease and stroke, indicating its effectiveness in improving balance control.
PBT, particularly when using treadmill-based systems and therapist-applied perturbations, is a feasible intervention in clinical settings that may benefit frail older adults, although further controlled studies with long-term follow-up are needed to confirm these findings.
Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice.Gerards, MHG., McCrum, C., Mansfield, A., et al.[2023]
A review of nine studies involving 364 participants found insufficient evidence that perturbation-based balance training effectively reduces falls in individuals with stroke.
The training protocols varied widely among studies, leading to inconsistent results regarding the impact of this training on common fall risk factors, highlighting the need for more high-quality research in this area.
A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke.Brown, D., Simpkins, C., Yang, F.[2023]
This study investigates the effectiveness of perturbation-based balance training (PBT) compared to conventional intensive balance training (CIBT) in improving reactive stepping ability in 24 adults with chronic incomplete spinal cord injury over 8 weeks.
The primary outcome measures the ability to recover balance using a single step, which will help determine which training method is more effective for enhancing balance control and reducing fall risk in this population.
Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial.Unger, J., Chan, K., Scovil, CY., et al.[2023]

Citations

A Systematic Review and Meta-Analysis - PMCPBT may improve balance in patients with stroke, however its effect on balance confidence was limited. The quality of the evidence was low or very low.
Stroke patient rehabilitation: an analysis of the effects of ...Perturbation training significantly improved the balance and walking efficiency of stroke patients, especially those with severe balance issues.
A systematic review of perturbation-based balance training ...The results indicated insufficient evidence supporting that perturbation-based balance training reduces falls in the laboratory and everyday living conditions ...
International Journal of Rehabilitation ResearchPerturbation-based balance training (PBT) has been shown to improve reactive balancing abilities in chronic stroke. To inform future investigations in the ...
The Effectiveness of Perturbation-Based Training in the ...PBT may improve balance in patients with stroke, however its effect on balance confidence was limited. The quality of the evidence was low or very low.
Stroke patient rehabilitation: an analysis of the effects ...Perturbation training significantly improved the balance and walking efficiency of stroke patients, especially those with severe balance issues, ...
The effect of perturbation-based balance training on balance ...Results from two meta-analyses indicate that PBT can significantly reduce daily-life fall rates by 46% and 52%, respectively [23, 24].
Perturbation-Based Balance TrainingPBT has shown significant reductions in falls in older adults and in those with specific disorders eg Parkinson's disease or stroke compared to various control ...
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