Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

NCT07042152 | Recruiting

• 1 other identifier: 2621
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Stroke Patients

Keywords

Sensor; SmartWatch; Stroke Recovery; Stroke Rehabilitation; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Variability Measurement

  The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed.

  From enrollment to the end of treatment and follow up measurement (9 weeks)

Secondary Outcomes (10)

• Active Time

  From enrollment to the end of treatment and follow up measurement (9 weeks)

• Fugl-Meyer Arm Motor Assessment

  Initial Visit, First follow up, Second follow up

• Box and Blocks Test

  Initial Visit, First follow up, second follow up

• Nine Hole Peg Test

  Initial Visit, First follow up, Second follow up

• Motor Activity Log (MAL)

  Initial Visit, First follow up, Second follow up

Other Outcomes (6)

• Geriatric Depression Scale

  Initial Visit, First follow up, Second follow up

• Intrinsic Motivation Inventory (IMI)

  Initial Visit, First follow up, Second follow up

• Modified Ashworth Spasticity Scale

  Initial Visit, First follow up, Second follow up

Study Arms (2)

Movement Variability

EXPERIMENTAL

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.

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

Active Time (Control)

PLACEBO COMPARATOR

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.

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

Interventions

Smartwatch App for Movement Variability OTHER

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

Movement Variability

Smartwatch App for Active Time OTHER

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

Active Time (Control)

Motivational Interviewing (Within Subjects) 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); Movement Variability

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36146287 BACKGROUND

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Reinkensmeyer, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicky Chan, DPT

CONTACT

9498248423; vchan2@uci.edu

Natanya Gunn, Medical Student

CONTACT

natanyag@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 27, 2025
• Study Start: August 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 29, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)