Effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in Enhancing Arm Function Post-Stroke

Status unconfirmed · Early Phase 1 · Has a placebo group

Conditions studied: Stroke

In brief

The goal of this clinical trial is to test the effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in improving arm function after a stroke. The main questions it aims to answer are 1) Does startle rehabilitation therapy improve functional arm performance after training on a specific task and 2) Can training benefits, if any, be seen in other untrained tasks? Researchers will enroll participants across a wide range of upper extremity impairments post-stroke. Participants will be enrolled in three consecutive days of in-person training on an upper extremity task followed by a single-day follow-up session one month after training is completed. Each training session will last for approximately 3 hours per day. Participants will be randomly assigned to one of two groups; 1) Arm training with START and 2) Arm training without START. Study participants and assessors will be blinded to the type of training received. Before the training, participants will be clinically assessed to determine impairment level. During training, participants will be asked to perform; 1) a simulated feed task which involves transferring kidney beans using a spoon from one cup (start position) to another cup (end position) in front of them OR 2) A functional reaching task where participants will maintain a tool (spoon) in their hand while extending their arm forward towards an end position based on the severity of arm impairment as determined by the clinical assessment. Researchers will compare the % change in trained task scores, muscle activity, and arm movement outcome measures at three-time points; baseline on day 1, at the end of training on day 3, and one month after training.

Key facts

Study ID

NCT05881096

Run by

Arizona State University

People needed

30

Starts

2022-06-07

Expected to finish

2023-12-01

Last updated by the study team

2023-06-01

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years old
• Capacity to provide informed consent
• Cerebral stroke at least 6 months prior to testing
• Presence of severe-to-mild upper extremity impairment
• Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender. NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. The investigators expect that \~30% of participants will use hearing aids; the investigators will not exclude these individuals but rather include hearing aid use as a covariate in analyses.

You may not qualify if…

• Severe concurrent medical problems (e.g. uncontrolled cardiorespiratory impairment)
• Acute/painful condition/injury of upper extremity/spine that interfere with ability to participate.

Where it is running

• Arizona State University — Tempe, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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