Startle Adjuvant Rehabilitation Therapy for Stroke

Overseen By Claire F Honeycutt, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Arizona State University

Disqualifiers: Uncontrolled cardiorespiratory impairment, acute/painful condition, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using a loud sound during physical therapy can help stroke survivors improve arm function. It targets stroke patients with arm impairments, especially those who struggle with traditional rehab. The sound helps 'wake up' the brain, making therapy more effective.

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 START - Startle Adjuvant Rehabilitation Therapy for Stroke?

Research shows that starting rehabilitation early after a stroke can improve recovery, and this is a key part of effective stroke care. Although specific data on START is not provided, early rehabilitation in general is linked to better outcomes. ^{1 2 3 4 5}

Is Startle Adjuvant Rehabilitation Therapy (START) safe for humans?

The research on StartReact, which is similar to START, shows it can increase muscle activity and reaction times in stroke survivors without reported safety issues. However, more studies are needed to fully understand its safety in rehabilitation. ^{2 6 7 8 9}

How is the START treatment different from other stroke rehabilitation treatments?

The START (Startle Adjuvant Rehabilitation Therapy) treatment is unique because it potentially incorporates startle reflexes to enhance rehabilitation, which is not a common approach in traditional stroke therapies that focus on physical exercises and motor learning. This novel method may offer a different mechanism to stimulate recovery compared to conventional therapies. ^{1 2 10 11 12}

Eligibility Criteria

Inclusion Criteria

You have a significant arm or hand disability.

You had a stroke at least 6 months ago.

Your hearing will be tested, and the results will be compared to what is considered normal for your age and gender. If you use a hearing aid, that information will also be taken into account.

Exclusion Criteria

You have a painful arm or spine injury that makes it hard for you to take part.

Severe concurrent medical problems (e.g. uncontrolled cardiorespiratory impairment)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants undergo three consecutive days of in-person training on an upper extremity task

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up session one month after training

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Sham Control
• START - Startle Adjuvant Rehabilitation Therapy

Participant Groups

Group I: START (Startle Adjuvant Rehabilitation Therapy) Experimental Treatment 1 Intervention

Participants in this group practice a functional reaching task with the START condition (startling acoustic stimuli applied during 33% of trials).

Group II: Control Placebo Group 1 Intervention

Participants in this group will practice a functional reaching task without the START (Startle Adjuvant Rehabilitation Therapy) intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

In a study involving 2,104 stroke patients, early and frequent mobilization (starting within 24 hours) significantly improved the odds of favorable outcomes at 3 months, with an odds ratio of 1.13 for increased session frequency.

However, increasing the total amount of mobilization time per day was associated with reduced odds of a good outcome, indicating that shorter, more frequent sessions are more beneficial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Bernhardt, J., Churilov, L., Ellery, F., et al.[2021]

Early initiation of rehabilitation services and increased functional skills upon admission are strongly associated with better functional outcomes for stroke patients at hospital discharge and follow-up, based on a review of 79 studies from 1950 to 1998.

Rehabilitation in an interdisciplinary setting (where different types of healthcare professionals work together) is more effective than a multidisciplinary approach (where professionals work separately), while factors like specialized therapy types and therapy intensity show a weak relationship with improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting functional outcome after stroke: a critical review of rehabilitation interventions. Cifu, DX., Stewart, DG.[2019]

A novel dose-finding design for stroke rehabilitation was developed, using a 3+3 rule-based approach that adjusted exercise repetitions based on participant tolerance, with a maximum tolerated dose identified at 209 repetitions per day.

The study involved five cohorts of participants with a mean age of 68 years, demonstrating that this method is feasible for optimizing rehabilitation doses to enhance motor function in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development. Colucci, E., Clark, A., Lang, CE., et al.[2018]

Conventional rehabilitation strategies for stroke patients, such as Bobath and motor relearning, remain the primary methods used in clinical practice, but there is a growing incorporation of advanced techniques like robotics and virtual reality to enhance recovery.

The proposal of an integrated training package that combines various rehabilitation methods tailored to the patient's recovery phase could lead to significant functional improvements for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. Chen, JC., Shaw, FZ.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial. [2021]

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

Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). [2021]

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

When should rehabilitation begin after stroke? [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Early Rehabilitation on Outcomes in Patients With Acute Ischemic Stroke After Endovascular Treatment. [2022]

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

Factors affecting functional outcome after stroke: a critical review of rehabilitation interventions. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

StartReact increases the probability of muscle activity and distance in severe/moderate stroke survivors during two-dimensional reaching task. [2021]

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

Impact of Startling Acoustic Stimuli on Word Repetition in Individuals With Aphasia and Apraxia of Speech Following Stroke. [2022]

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

A systematic review with meta-analysis of the StartReact effect on motor responses in stroke survivors and healthy individuals. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development. [2018]

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

Task-specific physical therapy for optimization of gait recovery in acute stroke patients. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of Physical Therapy Interventions for Stroke Rehabilitation: Impairment-Based Approaches and Functional Goals. [2023]

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

Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. [2022]