NCT07042152 · University of California, Irvine
Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
What this study is about
The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses treatment group$1 movement in improving upper extremity function in a pilot, randomly assigned controlled trial with chronic stroke patients
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Irvine, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations