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New treatment option for Chronic Stroke Patients
Official title Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
ClinicalTrials.gov ID: NCT07042152
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- 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...
- Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale \< 10.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.