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

Description

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.

Conditions

Stroke

Study Overview

Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Tempe

Arizona State University, Tempe, Arizona, United States, 85287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. \>18 years old
  • 2. Capacity to provide informed consent
  • 3. Cerebral stroke at least 6 months prior to testing
  • 4. Presence of severe-to-mild upper extremity impairment
  • 5. 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.
  • 1. Severe concurrent medical problems (e.g. uncontrolled cardiorespiratory impairment)
  • 2. Acute/painful condition/injury of upper extremity/spine that interfere with ability to participate.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arizona State University,

Study Record Dates

2023-12