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NCT05277389 · ClinicalTrials.gov registry record · Early Phase 1
New Tool to Enhance Post-stroke Upper Extremity Disability
A Early Phase 1 study of Stroke, sponsored by Arizona State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05277389 is a Early Phase 1 study of Stroke that has completed, run by Arizona State University. The registered enrollment target is 21 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05277389, a Early Phase 1 study of Stroke, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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 t
Conditions Studied
Interventions
- OTHER Sham Control
- OTHER START - Startle Adjuvant Rehabilitation Therapy
Study Locations (1)
Arizona
- Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2023-12-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05277389
The ClinicalTrials.gov registry entry for NCT05277389 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Sham Control is the first listed.
NCT05277389 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT05277389 about?
NCT05277389 is a clinical study titled "New Tool to Enhance Post-stroke Upper Extremity Disability". 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 ...
What is the current status of trial NCT05277389?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2022-12-20. Estimated completion is 2023-12-15.
What conditions does trial NCT05277389 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT05277389?
The interventions under investigation include: Sham Control (OTHER), START - Startle Adjuvant Rehabilitation Therapy (OTHER).
Who is sponsoring clinical trial NCT05277389?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05277389 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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