Recruiting

Behavioral Support

Sponsor:

UCLA

Code:

NCT07042152

Conditions

Chronic Stroke Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Smartwatch App for Movement Variability

Smartwatch App for Active Time

Motivational Interviewing (Within Subjects)

Study Details

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

Study ID

NCT07042152

Start date

Aug 20, 2025

Status verified date

Aug, 2025

Completion date

Jan 29, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

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).

Smartwatch App for Active Time

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

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.

Primary outcome measure

  • Variability Measurement [ Time Frame: From enrollment to the end of treatment and follow up measurement (9 weeks) ]

Central Contacts and Locations

Central contacts

Vicky Chan, DPT

9498248423vchan2@uci.edu

Natanya Gunn, Medical Student

natanyag@hs.uci.edu

Locations

University of California Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Vicky Chan, DPT

949-824-8423vchan2@uci.edu

Principal Investigator:

David Reinkensmeyer, PhD

More Information

Sponsor

University of California, Irvine

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • Sensor
  • SmartWatch
  • Stroke Recovery
  • Stroke Rehabilitation
  • Motivational Interviewing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-08-19.