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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special therapy called START (Startle Adjuvant Rehabilitation Therapy) can help stroke survivors improve arm function. Researchers will divide participants into two groups: one will receive the therapy with a startle sound, and the other will not. The study will evaluate whether this therapy aids specific arm tasks and if the benefits extend to other tasks. Ideal participants are those who had a stroke over six months ago and have difficulty using their arms. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative therapy.

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 this rehabilitation therapy is safe for stroke patients?

Research has shown that Startle Adjuvant Rehabilitation Therapy (START) can improve muscle movement and reaction times in stroke patients. Importantly, no safety problems have been reported, indicating that patients tolerate it well.

START uses sudden sounds to enhance the benefits of rehabilitation exercises. In past studies, participants did not experience negative effects from this method. This is promising for anyone considering joining a trial that includes START.

While more research is always beneficial, current evidence offers a positive view of START's safety for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Startle Adjuvant Rehabilitation Therapy (START) for stroke recovery because it introduces a novel approach by incorporating startling acoustic stimuli to enhance rehabilitation. Unlike conventional therapies that mainly focus on physical exercises and motor skills training, START uses sudden sounds during therapy to potentially boost the brain's responsiveness and enhance motor function recovery. This innovative technique may accelerate progress and improve outcomes for stroke survivors by engaging neural pathways in a unique way.

What evidence suggests that START might be an effective treatment for improving arm function after a stroke?

Research has shown that starting rehabilitation early can lead to better recovery for stroke survivors. In this trial, participants will join one of two groups: one receiving START (Startle Adjuvant Rehabilitation Therapy) and the other a control group without the START intervention. Although specific data on START is not yet available, early treatments often improve movement abilities. Other studies have found that sounds can help reduce language and movement difficulties after a stroke. START aims to use sudden sounds to boost the brain's ability to relearn arm movement. While data from human studies is limited, early signs suggest that START could enhance arm movement after a stroke. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Sham Control
• START - Startle Adjuvant Rehabilitation Therapy

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05881096/effectiveness-of-start-startle-adjuvant-rehabilitation-therapy-in-enhancing-arm-function-post-stroke?activelyRecruiting=false&page=71&id=42&slug=cerebral-ischemia

Effectiveness of START (Startle Adjuvant Rehabilitation ... The goal of this clinical trial is to test the effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in improving arm function ...

2. withpower.com withpower.com/trial/startle-adjuvant-rehabilitation-therapy-for-stroke-4fc5a

Startle Adjuvant Rehabilitation Therapy for Stroke Although specific data on START is not provided, early rehabilitation in general is linked to better outcomes.

3. smartpatients.com smartpatients.com/trials/NCT05881096

Effectiveness of START (Startle Adjuvant Rehabilitation ... The goal of this clinical trial is to test the effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in improving arm function after a stroke.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10454263/

Application of action observation therapy in stroke ... They found that 4 weeks' AOT intervention significantly increased patient motor function and arm function compared with standard rehabilitation ...

5. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2023_AJSLP-22-00296

A Stratified, Single-Blind, Randomized, Phase 1 Clinical Trial Word Repetition Paired With Startling Stimuli Decreases Aphasia and Apraxia Severity in Severe-to-Moderate Stroke: A Stratified, Single-Blind, Randomized, Phase ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37699161/

A Stratified, Single-Blind, Randomized, Phase 1 Clinical Trial The START group had increased mood and perceived communication recovery by Day 5, whereas controls saw no changes in quality of life. ...