New Tool to Enhance Post-stroke Upper Extremity Disability

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Arizona State University
Study ID
NCT05277389
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • START - Startle Adjuvant Rehabilitation Therapy — OTHER
    Application of startling acoustic stimuli during practice of movement task
  • Sham Control — OTHER
    Practice of Movement task without START

Study Details

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.

Key Dates

Start date
Dec 20, 2022
Status verified
Jun 2025
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Change in Action Research Arm Test (ARAT) Total Score From Baseline to Post-Intervention [ Time Frame: Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona State UniversityTempeArizona85287-

Find similar trials in Tempe, AZ

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Arizona State University· Tempe, AZ

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