Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

University of California Irvine (UCI)

Status: Enrolling

Conditions: Chronic Stroke Patients

Treatments: Behavioral: Motivational Interviewing (Within Subjects); Other: Smartwatch App for Active Time; Other: Smartwatch App for Movement Variability

Study type: Interventional

Funder types: Other

Identifiers

NCT07042152

2621

Details and patient eligibility

About

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

Full 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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

Movement Variability

Experimental group

Description:

The movement variability group will have a smartwatch app that records movement variability. Their movement goal will be centered on increasing their total movement variability as measured by the watch.

Treatment:

Other: Smartwatch App for Movement Variability

Behavioral: Motivational Interviewing (Within Subjects)

Active Time (Control)

Placebo Comparator group

Description:

This group will only receive active-time feedback (the number of minutes and hours moving the upper extremity). Their goal will focus on increasing their total movement time.

Treatment:

Other: Smartwatch App for Active Time

Behavioral: Motivational Interviewing (Within Subjects)