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Not recruiting
Early Phase 1

Post-Stroke Tool

Sponsor:

Arizona State University

Code:

NCT05277389

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:

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, we need to 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: we 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. We 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

Study ID

NCT05277389

Start date

Dec 15, 2021

Status verified date

Mar, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Mar, 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-moderate upper extremity impairment (UEFM < 42/66)
5. 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.

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Control

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

experimental: START

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

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 Action Research Arm Test (ARAT) baseline to post [ Time Frame: Change in ARAT from baseline (before training) to post (within 3 days of completed training) ]
  • Retention in Action Research Arm Test (ARAT) [ Time Frame: Retention of ARAT comparing post ARAT (within 3 days of completed training) to one-month post ]
  • Change in Motor Activity Log (MAL) [ Time Frame: Change in measure from baseline (before training) to post (within 3 days of completed training) ]
  • Retention in Motor Activity Log (MAL) [ Time Frame: Retention of measure comparing post (within 3 days of completed training) to one-month post ]

Central Contacts and Locations

Central contacts

Claire F Honeycutt, PhD

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

Mar 14, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by Arizona State University on 2022-03-14.