Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
ConditionChronic Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity of California, Irvine
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Smartwatch App for Movement Variability
- Smartwatch App for Active Time
- Motivational Interviewing (Within Subjects)
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov