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Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Recruiting
18-84 years
All
Phase N/A

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Overview

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

Description

In this randomized controlled trial, the investigators will evaluate two telerehabilitation strategies for increasing arm use at home: a smartwatch app and a psychological intervention. The psychological intervention aims to address ambivalence and enhance motivation, while the smartwatch provides feedback on arm movement variability. The investigators hypothesize that combining the psychological intervention with smartwatch feedback will lead to greater improvements in arm use and upper extremity recovery

Eligibility

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

Study details
    Chronic Stroke Patients

NCT07042152

University of California, Irvine

15 October 2025

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