RecruitingNot ApplicableNCT07042152

Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Sensor Enhanced Activity Motivation After Stroke

Sponsor

University of California, Irvine

Enrollment

32 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Stroke Patients

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

Min Age: 18 YearsMax Age: 84 Years

Inclusion Criteria4

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 Criteria13

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

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Interventions

OTHERSmartwatch App for Movement Variability

This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).

OTHERSmartwatch App for Active Time

The other software we are using measures total active time of the upper extremity.

BEHAVIORALMotivational Interviewing (Within Subjects)

Motivational Interviewing is an established therapeutic technique designed to increase patient adherence to therapy by addressing ambivalence. The motivational Interviewing sessions will include a variety of techniques such as: Open ended questions, Active Listening, Affirmation, Summarization, Questions focused on change talk, and Providing Information.