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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: Completed Early Phase 1 study of Stroke, sponsored by Arizona State University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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 uppe

Conditions Studied

Interventions

  • OTHER Sham Control
  • OTHER START - Startle Adjuvant Rehabilitation Therapy

Study Locations (1)

Arizona

  • Arizona State University - Tempe

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2022-12-20
Est. Completion 2023-12-15
Phase Early Phase 1
Arizona State University

187 total trials

What the finished NCT05277389 record still lists

NCT05277389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05277389's enrollment target sits among peer trials

21 356th of 454 higher than 95 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05277389, the US trial registry maintained by the National Library of Medicine. NCT05277389 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.