Recruiting
Early Phase 1

START

Sponsor:

Arizona State University

Code:

NCT05881096

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

START - Startle Adjuvant Rehabilitation Therapy

Sham Control

Study Details

Brief summary:

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 ID

NCT05881096

Start date

Jun 7, 2022

Status verified date

May, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: START (Startle Adjuvant Rehabilitation Therapy)

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

sham comparator: Control

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

Interventions

START - Startle Adjuvant Rehabilitation Therapy

Application of startling acoustic stimuli during practice of movement task

Sham Control

Practice of movement task without START

Primary outcome measure

  • Change in EMG (electromyography) onset (in ms) during functional reaching task [ Time Frame: Change in EMG onset from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in EMG (electromyography) amplitude (in mV) during the functional reaching task [ Time Frame: Change in EMG amplitude from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in movement onset (in ms) on functional reaching task [ Time Frame: Change in movement onset from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in movement linearity (in mm) on functional reaching task [ Time Frame: Change in movement linearity from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in functional reaching task scores during training [ Time Frame: Change in functional reaching task scores from on day 1 of training compared to day 3 of training ]
  • Change in functional reaching task scores [ Time Frame: Change in functional reaching task scores from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in sorting task scores [ Time Frame: Change in sorting task scores from baseline (before training on day 1) to post (after training on day 3) ]
  • Change in dressing task scores [ Time Frame: Change in dressing task scores from baseline (before training on day 1) to post (after training on day 3) ]

Central Contacts and Locations

Central contacts

Claire F Honeycutt, Ph.D

480- 965-8453cfhoneyc@asu.edu

Locations

Arizona State University

Recruiting

Tempe, Arizona, United States, 85287

Contacts

More Information

Sponsor

Arizona State University

Last update posted

Jun 1, 2023

Last verified

May, 2023

Keywords

  • Hemiplegia
  • Upper extremity impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2023-06-01.