Perturbation Training for Alzheimer's Disease

(STAD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Feng Yang, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgia State University

Disqualifiers: Hypotension, Hypertension, Osteoporosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will examine the overall capacity of people with Alzheimer's disease learning fall-resistant skills from perturbation training.

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.

What data supports the effectiveness of the treatment Perturbation Training for Alzheimer's Disease?

Research shows that perturbation-based balance training (PBT) can significantly reduce falls in older adults and people with conditions like Parkinson's disease and stroke. This suggests that PBT might help improve balance and reduce falls in Alzheimer's patients as well, although more specific studies are needed. ^{1 2 3 4 5}

Is perturbation training safe for humans?

Perturbation training, which helps improve balance and prevent falls, has been studied in older adults and people with neurological conditions like Parkinson's disease and stroke. While it shows promise in reducing falls, more research is needed to fully understand its safety and effectiveness in different groups. ^{3 5 6 7 8}

How is perturbation training different from other treatments for Alzheimer's disease?

Perturbation training is unique because it focuses on improving reactive balance control by repeatedly exposing participants to unexpected movements that challenge their balance, which is different from traditional exercise programs that may not specifically target fall prevention. This approach is emerging as a promising method to reduce falls, particularly in older adults and those with neurological conditions. ^{1 3 6 7 9}

Research Team

Feng Yang, PhD

Principal Investigator

Georgia State University

Eligibility Criteria

This trial is for English-speaking individuals aged 65 or older with probable Alzheimer's Disease who can walk and stand independently. They must have certain scores on cognitive tests indicating moderate impairment but cannot have had perturbation training before, osteoporosis, other major psychiatric or neurological conditions, injuries, or uncontrolled blood pressure issues.

Inclusion Criteria

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

I can walk by myself for at least 25 feet.

Participants can read and understand English

Exclusion Criteria

I have a psychiatric or neurological condition.

I have very low or uncontrolled high blood pressure.

You have never received perturbation training.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness

1 session

1 visit (in-person)

Control

Control group undergoes harnessed walking on the treadmill without perturbation training

1 session

1 visit (in-person)

Follow-up

Participants are monitored for fall incidents and skill retention over six months

6 months

Periodic assessments (in-person)

Treatment Details

Interventions

• Perturbation training (Behavioral Intervention)

Trial Overview The study is testing the effectiveness of perturbation training in teaching people with Alzheimer's Disease how to resist falls better. Perturbation training involves controlled exposure to disturbances that challenge balance.

Participant Groups

Group I: Training group Experimental Treatment 1 Intervention

This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.

Group II: Control group Placebo Group 1 Intervention

This arm will not receive perturbation training but will go through harnessed walking on the same treadmill for the same time as the other group.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Dr. Jian-Dong Li

Georgia State University

Chief Executive Officer since 2011

PhD in Biomedical Sciences from University of California, San Francisco; MD from Qingdao University School of Medicine

Dr. Steve Simonson

Georgia State University

Chief Medical Officer since 2014

MD from Medical College of Wisconsin; Master's in Health Sciences from Duke University School of Medicine

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

Dr. Joanne Pike

Alzheimer's Association

Chief Executive Officer since 2023

DrPH in Public Health Leadership from the University of North Carolina at Chapel Hill

Dr. Maria C. Carrillo

Alzheimer's Association

Chief Medical Officer

PhD in Neuroscience

Findings from Research

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]

A short-term perturbation-based balance training (PBBT) program significantly improved reactive balance responses in stroke patients, as evidenced by higher multiple-step thresholds compared to a weight shifting and gait training group, with effect sizes of 1.07 and 1.10 for forward and backward translations, respectively.

Participants in the PBBT group also reported increased balance confidence, indicated by a moderate effect size of 0.74 on the Activity-specific Balance Confidence scale, highlighting the potential of PBBT in enhancing both physical and psychological aspects of balance in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Perturbation-Based Balance Training in Subacute Persons With Stroke: A Randomized Controlled Trial. Handelzalts, S., Kenner-Furman, M., Gray, G., et al.[2019]

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]

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]

The study aims to evaluate whether perturbation-based balance training can effectively reduce fall occurrences in individuals with chronic stroke, addressing a significant post-stroke complication.

Participants will undergo training twice a week for 6 weeks, with follow-up assessments on falls and balance confidence over 12 months, potentially leading to improved mobility and daily activity engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. Mansfield, A., Aqui, A., Centen, A., et al.[2019]

In a study involving 45 older adults, increasing the practice dosage of treadmill slip-perturbation training to 40 repetitions did not lead to a significant reduction in falls or balance loss compared to a lower dosage of 24 repetitions.

The findings suggest that there is no clear dose-response relationship for practice dosage in slip-perturbation training, indicating that more repetitions beyond a certain threshold may not enhance the effectiveness of training for preventing falls in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can higher training practice dosage with treadmill slip-perturbation necessarily reduce risk of falls following overground slip? Lee, A., Bhatt, T., Liu, X., et al.[2021]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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

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

Effects of Perturbation-Based Balance Training in Subacute Persons With Stroke: A Randomized Controlled Trial. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. 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]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. [2019]

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

Can higher training practice dosage with treadmill slip-perturbation necessarily reduce risk of falls following overground slip? [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Interindividual Balance Adaptations in Response to Perturbation Treadmill Training in Persons With Parkinson Disease. [2020]