Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
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
| Condition(s) | Chronic Stroke Patients |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 m |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Lead sponsor | University of California, Irvine |
| Locations | Irvine, California, United States |
| Start date | 2025-08-20 |
| NCT ID | NCT07042152 |
| Official listing | https://clinicaltrials.gov/study/NCT07042152 |