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START - Startle Adjuvant Rehabilitation Therapy for Stroke

Phase < 1
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capacity to provide informed consent
>18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up retention of arat comparing post arat (within 3 days of completed training) to one-month post
Awards & highlights

Study Summary

This trial is testing a tool, START, which has the potential to directly target the causes leading to disparity of care for individuals with low socioeconomic status (SES). START is adjuvant, meaning it does not replace clinical practice but instead enhances current evidence-based treatments. The objective of this study is to determine if START can be used to enhance functionally relevant movement of the upper extremity in a group of 58 subjects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You fully understand what the study involves and agree to participate.
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You must be above 18 years of age.
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You had a stroke in your brain at least 6 months ago.
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You have difficulty moving your arms and hands, with a score of less than 42 out of 66 on a test called UEFM.
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You will have a hearing test to determine if you can hear sounds at certain frequencies, based on your age and gender. The test will be done in a quiet room by trained personnel, and if you use hearing aids, that will be taken into account during the analysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~retention of measure comparing post (within 3 days of completed training) to one-month post
This trial's timeline: 3 weeks for screening, Varies for treatment, and retention of measure comparing post (within 3 days of completed training) to one-month post for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Action Research Arm Test (ARAT) baseline to post
Change in Motor Activity Log (MAL)
Retention in Action Research Arm Test (ARAT)
+1 more
Secondary outcome measures
Change in Modified Tardieu
Change in Stroke Impact Scale
Change in Upper extremity fugl meyer (UEFM)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: STARTExperimental Treatment1 Intervention
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials)
Group II: ControlPlacebo Group1 Intervention
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,454 Total Patients Enrolled
4 Trials studying Stroke
118 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chief aims of this trial?

"This clinical trial aims to assess motor activity log retention and changes over a one month period through post-training evaluations. Secondary metrics include upper extremity Fugl-Meyer tests, Fugl Meyer retention assessments, and Modified Tardieu spasticity measurements."

Answered by AI

What is the current extent of enrolment in this research?

"Affirmative. According to information hosted on clinicaltrials.gov, this trial is actively sourcing participants and was originally posted December 15th 2021. It requires 60 volunteers from one medical centre for participation."

Answered by AI

Are new participants being welcomed into this experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on December 15th 2021, is actively recruiting patients at present. The team needs to onboard 60 individuals from a single research centre."

Answered by AI

Who is qualified to partake in this exploration?

"This research project is seeking 60 individuals who have experienced a stroke in the 18-99 year old age bracket. In order to be eligible, applicants must provide informed consent, demonstrate suitable auditory thresholds according to their gender and age group, present moderate or severe deficits in upper extremity function (UEFM < 42/66), and possess at least 6 months worth of medical history surrounding their cerebrovascular accident . An estimated 30 percent participants will wear hearing aids; these devices should not disqualify them from consideration but instead be taken into account as part of data analysis."

Answered by AI

Is this experimental research seeking participants over 20 years of age?

"The age range of participants for this study stretches from 18 years old to 99 years old."

Answered by AI
~18 spots leftby Apr 2025