New Tool to Enhance Post-stroke Upper Extremity Disability

NCT05277389 | Completed Early Phase 1 Results

• 1 other identifier: STUDY00002440
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with low socioeconomic status (SES) are more likely to have a stroke, more disabled at 3 months, and less likely to be independently ambulatory. Individuals with low SES struggle to adhere to physician guidelines because of 1) increased disability leaves patients ineligible or unable to tolerate therapy, and 2) poor access to quality care i.e., lack of transportation to therapy. To reduce post-stroke disparity in low SES groups, society must invest in development of novel tools that make therapy more accessible. For the past 5 years, the PI has been developing Startle Adjuvant Rehabilitation Therapy (START), a tele-enabled, low-cost treatment to improve upper-extremity therapy outcomes in individuals with stroke - in particular individuals with severe-to-moderate stroke. START is the application of a startling, acoustic stimulus (via headphones) which increases the intensity of practice, particularly in severe patient populations. START is adjuvant, meaning it does not replace clinical practice but instead enhances current evidence-based treatments. Objective: the investigators seek to determine if START can be used to enhance functionally relevant movement of the upper extremity. Preliminary data: Individuals with severe-to-moderate disability from a stroke completed a remotely delivered, 3-day training of object manipulation with START. Box and Blocks, which was targeted during training, demonstrated a large increase under START (+47.1%) compared to Control (+3.3%). Modified functional reach was also increased under START (+8.9%) compared to Control (+1.1%). Impairment also decreased under START (Upper-Extremity-Fugl-Meyer: +8.6%) resulting in subject-reported increase in arm function both in quantity (Motor Activity Log: +26.2%) and quality (+20.2%). These results indicate that START can be deployed remotely and may prove a valuable, adjuvant tool to enhance functional upper extremity movement. The investigators propose to perform a Phase 1 clinical trial on a larger cohort of 58 subjects, with a longer, 5-day training with the goal of establishing that START can 1) enhance functional movement of the upper extremity and 2) generate sustainable changes that impact quality of life. Impact: This proposal is significant because it tests a tool that has the potential to directly target the causes leading to disparity of care for individuals with low SES. A third (34%) of 6.5 million people in the U.S. with stroke are on Medicaid or uninsured. Our best evidence-based therapies (e.g., high-intensity, CIMT) and our emerging rehabilitation technologies (e.g., TMS, robotics) are inaccessible to our minority and low SES populations. START addresses disparity because it 1) targets individuals with severe disability, which disproportionally affects low SES and minority groups, and 2) is tele-enabled eliminating transportation which 60% of individuals with low SES report as a barrier to care. If successful, this study will set the stage for larger trials to establish 1) the effectiveness of START to be incorporated into traditional therapy and as well as patient compliance, adherence, and tolerance - particularly in low SES groups.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Change in Action Research Arm Test (ARAT) Total Score From Baseline to Post-Intervention

  The Action Research Arm Test (ARAT) assesses upper extremity function, specifically arm and hand motor abilities, in individuals with neurological conditions. The test evaluates grasp, grip, pinch, and gross movement through 19 standardized tasks. Each task is scored from 0 (no movement) to 3 (normal movement), yielding four subscale scores (Grasp, Grip, Pinch, Gross Movement) that are summed to compute a total score. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function. Subscale ranges are: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). The outcome measure reports the change in the total ARAT score from baseline to post-intervention, with positive values reflecting improved function. Scores are reported as units on a scale.

  Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

• Retention in Action Research Arm Test (ARAT)

  The Action Research Arm Test (ARAT) assesses upper extremity function, specifically arm and hand motor abilities, in individuals with neurological conditions. The test evaluates grasp, grip, pinch, and gross movement through 19 standardized tasks. Each task is scored from 0 (no movement) to 3 (normal movement), yielding four subscale scores (Grasp, Grip, Pinch, Gross Movement) that are summed to compute a total score. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function. Subscale ranges are: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). The outcome measure reports the change in the total ARAT score from baseline to post-intervention, with positive values reflecting improved function. Scores are reported as units on a scale.

  Comparing baseline to one-month post (1 month post intervention - total 5 weeks time frame)

• Change in Motor Activity Log (MAL) Amount of Use Score From Baseline to Post-Intervention

  The Motor Activity Log (MAL) assesses arm use in daily activities post-stroke. The Amount of Use subscale (0-5) rates 30 tasks; higher scores mean more use. Total score averages task scores (0-5). Change in total score is reported. Units on a scale. MAL was taken at baseline and then at one-month post intervention.

  Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

• Retention in Motor Activity Log (MAL)

  The Motor Activity Log (MAL) assesses arm use in daily activities post-stroke. The Amount of Use (AOU) subscale (0-5) rates 30 tasks; higher scores indicate more use. The total score sums the 30 AOU task scores, ranging from 0 to 150. Units on a scale.

  Retention of measure comparing baseline to one-month

Secondary Outcomes (4)

• Change in Upper Extremity Fugl Meyer (UEFM) Baseline to Post-intervention

  Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

• Retention of Upper Extremity Fugl Meyer From End Training to One-month Post

  Retention of measure comparing baseline to one-month post training

• Change in Stroke Impact Scale From Baseline to Post-intervention

  Change from baseline to post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

• Retention of Stroke Impact Scale - Post-training to One-month Post

  Change from baseline to one-month post training

Study Arms (2)

Control

SHAM COMPARATOR

Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention

Other: Sham Control

START

EXPERIMENTAL

Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials)

Other: START - Startle Adjuvant Rehabilitation Therapy

Interventions

START - Startle Adjuvant Rehabilitation Therapy OTHER

Application of startling acoustic stimuli during practice of movement task

START

Sham Control OTHER

Practice of Movement task without START

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• Capacity to provide informed consent
• Cerebral stroke at least 6 months prior to testing
• Presence of upper extremity impairment associated with stroke
• Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender27,28 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. We expect that \~30% of participants will use hearing aids; we 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This trial was ended early as preliminary data assessed that it would not be successful. PI indicates that clinical assessment measures may not have been sensitive to pick up the small changes that the PI has previously picked up. Further, the trial was only 3 days in length and longer may be required to see changes.

Results Point of Contact

• Title: Claire Honeycutt, Associate Professor
• Organization: Arizona State University

claire.honeycutt@asu.edu

4809658453

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 14, 2022
• Study Start: December 20, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Locations

US (1)