Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

NCT ID: NCT07042152

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-01-29

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

Detailed 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

Conditions

Chronic Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Movement Variability

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.

Group Type: EXPERIMENTAL

Smartwatch App for Movement Variability

Intervention Type: OTHER

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

Motivational Interviewing (Within Subjects)

Intervention Type: BEHAVIORAL

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.

Active Time (Control)

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.

Group Type: PLACEBO_COMPARATOR

Smartwatch App for Active Time

Intervention Type: OTHER

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

Motivational Interviewing (Within Subjects)

Intervention Type: BEHAVIORAL

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.

Interventions

Smartwatch App for Movement Variability

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

Intervention Type: OTHER

Smartwatch App for Active Time

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

Intervention Type: OTHER

Motivational 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

David Reinkensmeyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Reinkensmeyer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California Irvine

Irvine, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vicky Chan, DPT

Role: CONTACT

vchan2@uci.edu

9498248423

Natanya Gunn, Medical Student

Role: CONTACT

natanyag@hs.uci.edu

Facility Contacts

Vicky Chan, DPT

Role: primary

vchan2@uci.edu

949-824-8423

References

Schwerz de Lucena D, Rowe JB, Okita S, Chan V, Cramer SC, Reinkensmeyer DJ. Providing Real-Time Wearable Feedback to Increase Hand Use after Stroke: A Randomized, Controlled Trial. Sensors (Basel). 2022 Sep 14;22(18):6938. doi: 10.3390/s22186938.

Reference Type: BACKGROUND

PMID: 36146287 (View on PubMed)

Other Identifiers

2621

Identifier Type: -

Identifier Source: org_study_id