Smartwatch plus coaching to increase affected arm use after stroke
Sensor Enhanced Activity Motivation After Stroke
This trial will test whether a smartwatch that tracks arm movement combined with short motivational coaching can help people with chronic stroke use their affected arm more in daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT07042152 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial enrolls adults with chronic unilateral weakness after stroke and compares telerehabilitation strategies that combine a smartwatch app with a brief psychological intervention based on motivational interviewing. The smartwatch app provides feedback on movement variability and active-use time while the coaching addresses ambivalence and boosts motivation to use the affected arm. Participants are randomized to receive different combinations of the smartwatch feedback and coaching, with baseline and follow-up assessments of real-world arm use and standardized upper-extremity motor tests. Most intervention delivery is remote, with enrollment and key outcome visits conducted at University of California, Irvine.
Who should consider this trial
Good fit: Adults 18–85 years old who had an ischemic or hemorrhagic stroke at least six months earlier with unilateral arm weakness, who can perform at least 3 blocks on the Box and Block Test with the affected arm and do not have major depression or severe spasticity, are ideal candidates.
Not a fit: Patients with recent strokes (<6 months), severe upper-extremity spasticity, major cognitive or psychiatric disorders, advanced organ failure, pregnancy, or those unable to attend enrollment/follow-up at the study site are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could help people with chronic stroke regain more functional use of their affected arm and improve independence in daily activities.
How similar studies have performed: Smaller studies and pilot trials have shown promising effects of wearable feedback or motivational interviewing separately for post-stroke activity, but combining these approaches in a randomized pilot for arm use is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California
- University of California Irvine — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: David Reinkensmeyer, PhD — University of California, Irvine
- Study coordinator: Vicky Chan, DPT
- Email: vchan2@uci.edu
- Phone: 9498248423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.