Smartwatch plus coaching to increase affected arm use after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.