Perturbation Training for Stroke

Overseen By Camden Jacobs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Cerebellar damage, Cardiac arrhythmias, Neurological disorders, Legal blindness, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

86 Participants Needed

Trial Summary

What is the purpose of this trial?

Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.

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 data supports the effectiveness of the treatment Proactive Perturbations, Perturbation-Based Balance Training, PBT, Mechanical Perturbation Training, Reactive Perturbations, Perturbation-Based Balance Training, Reactive Balance Training, Mechanical Perturbation Training for stroke?

Research shows that perturbation-based balance training (PBT) can improve balance control and reduce fall risk in people who have had a stroke. Studies indicate that PBT helps improve the ability to take reactive steps, which is crucial for maintaining balance and preventing falls. ^{1 2 3 4 5}

Is perturbation-based balance training safe for humans?

Perturbation-based balance training has been studied for its safety and effectiveness in improving balance and reducing falls, particularly in older adults and individuals with stroke. While it shows promise, some aspects of its safety and application need further investigation before widespread clinical use. ^{1 2 3 6 7}

How is the treatment Perturbation-Based Balance Training different from other treatments for stroke?

Perturbation-Based Balance Training is unique because it focuses on improving reactive balance control by exposing patients to controlled destabilizing movements, which helps them practice and enhance their ability to recover from potential falls. This task-specific approach is different from traditional balance training, which may not specifically target the quick, reactive steps needed to prevent falls. ^{1 2 3 5 6}

Research Team

Jesse Dean

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Reactive Perturbations Experimental Treatment 1 Intervention

Group II: Proactive Perturbations Experimental Treatment 1 Intervention

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+

Findings from Research

Perturbation-based balance training (PBT) significantly improved reactive balance control in individuals with chronic stroke, as evidenced by a decrease in the frequency of extra steps taken in response to support-surface perturbations after 6 weeks of training.

In contrast, traditional balance training did not show similar improvements, highlighting the effectiveness of PBT in rehabilitation programs aimed at reducing fall risk in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? Schinkel-Ivy, A., Huntley, AH., Aqui, A., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. Brown, D., Simpkins, C., Yang, F.[2023]

Perturbation-based balance training (PBT) significantly improved clinical mobility and reactive balancing abilities in three subacute stroke patients after 15 daily sessions, indicating its efficacy in enhancing balance post-stroke.

Improvements in reactive balancing were noted specifically for backward and inward perturbations, suggesting that PBT should be customized based on individual balance deficiencies identified through biomechanical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improving the specificity of perturbation-based training through assessment of dynamic balancing responses: a series of N-of-1 studies in subacute stroke. Zadravec, M., Olenšek, A., Rudolf, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Perturbation-based balance training is emerging as a promising method for preventing falls in older adults, focusing on task-specific training that may lead to better adaptation and retention of balance skills.

While the approach shows potential efficacy, further research is needed to address safety concerns and practical implementation issues before it can be widely adopted in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation-based balance training: Principles, mechanisms and implementation in clinical practice. McCrum, C., Bhatt, TS., Gerards, MHG., et al.[2023]

A study involving 82 older adults (average age 73) found that a perturbation-based balance training (PBT) program did not significantly improve balance control or reduce fear of falling compared to usual care alone after three weeks of training.

Despite using advanced technology and a structured training approach, the PBT did not yield clinically relevant improvements in balance, indicating a need for further research to optimize training methods and outcome measures for older adults at risk of falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of perturbation-based balance training on balance control and fear of falling in older adults: a single-blind randomised controlled trial. Gerards, M., Marcellis, R., Senden, R., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Toward improving the specificity of perturbation-based training through assessment of dynamic balancing responses: a series of N-of-1 studies in subacute stroke. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Perturbation-based balance training: Principles, mechanisms and implementation in clinical practice. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The effect of perturbation-based balance training on balance control and fear of falling in older adults: a single-blind randomised controlled trial. [2023]