Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07042152
Status
Recruiting

Conditions

  • Chronic Stroke Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

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).
  • Smartwatch App for Active Time — OTHER
    The other software we are using measures total active time of the upper extremity.
  • 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.

Study Details

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

Key Dates

Start date
Aug 20, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Jan 29, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92697
Vicky Chan, DPT
949-824-8423
David Reinkensmeyer, PhD (PRINCIPAL_INVESTIGATOR)

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