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Search / Trial NCT07042152

Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jun 19, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Sensor Smart Watch Stroke Recovery Stroke Rehabilitation Motivational Interviewing

ClinConnect Summary

This clinical trial is studying whether using a wearable device combined with behavioral support can help improve arm movement and function in people who have had a stroke more than six months ago. The wearable device tracks how much the affected arm is moving and provides feedback to encourage more use, while behavioral support helps motivate and guide participants. The goal is to see if this approach can help stroke survivors regain better use of their arm.

To join the study, participants need to be between 18 and 85 years old and have had one or more strokes that caused weakness on one side of the body at least six months before starting the trial. They should have some ability to move their affected arm, but it should be weaker than the other arm. People with serious depression, recent strokes, severe muscle stiffness, major health problems, or those currently in other stroke studies would not be eligible. Participants can expect to wear the device and receive support aimed at helping them use their arm more in daily life. This study is not yet recruiting, but it aims to find new ways to help people improve arm function after stroke.

Gender

ALL

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

About University Of California, Irvine

The University of California, Irvine (UCI) is a leading research institution renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a robust infrastructure for clinical research, UCI fosters interdisciplinary collaboration among its esteemed faculty and researchers, aiming to translate scientific discoveries into effective therapeutic solutions. The university prioritizes ethical standards and participant safety while addressing critical healthcare challenges across various fields, including cancer, neurology, and public health. UCI's dedication to excellence in research and education positions it as a pivotal contributor to the advancement of clinical science and patient care.

Locations

Irvine, California, United States

Patients applied

0 patients applied

Trial Officials

David Reinkensmeyer, PhD

Principal Investigator

University of California, Irvine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported