NCT07042152 Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
| NCT ID | NCT07042152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Chronic Stroke Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-08-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses arm movement in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients
Eligibility Criteria
Inclusion Criteria: * 18 to 85 years of age * Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously * An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm. * Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale \< 10. Exclusion Criteria: * Any substantial decrease in alertness, language reception, or attention * Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago * Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale) * Pregnant or lactating * Advanced liver, kidney, cardiac, or pulmonary disease * Coexistent major neurological disease * Coexistent major psychiatric disease * Plans to alter any current participation in other rehabilitation therapy in the time period of the study * A terminal medical diagnosis consistent with survival \< 1 year * A history of significant alcohol or drug abuse in the prior 3 years * Current enrollment in another study related to stroke or stroke recovery * Any other medical contraindication to participation in the study, as evaluated by our team physician. * Visual Analog of Pain Scale Score of 7 or greater
Contact & Investigator
David Reinkensmeyer, PhD
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT07042152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Chronic Stroke Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042152 currently recruiting?
Yes, NCT07042152 is actively recruiting participants. Contact the research team at vchan2@uci.edu for enrollment information.
Where is the NCT07042152 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT07042152 clinical trial?
NCT07042152 is sponsored by University of California, Irvine. The principal investigator is David Reinkensmeyer, PhD at University of California, Irvine. The trial plans to enroll 32 participants.
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