Wearable Device + Behavioral Support for Stroke

Overseen By Natanya Gunn, Medical Student

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Recent stroke, Severe spasticity, Major diseases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a wearable device and behavioral support can improve arm movement in individuals who have experienced a stroke. Participants will use either a smartwatch app that tracks the variety of their movements or one that simply records arm movement. The study seeks individuals who had a stroke over six months ago and have difficulty moving one arm. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this wearable device and behavioral support are safe for stroke patients?

Research shows that wearable devices, like the one used in this trial, have helped stroke patients recover. These devices track movement and provide feedback, which aids rehabilitation. Previous studies found that wearable devices are generally safe and well-tolerated by stroke patients, with no reports of serious negative side effects.

The behavioral support component, which includes guidance and coaching, is also safe. It functions like a personal coach to help improve movements. This combination of technology and support aims to make recovery smoother and more effective without adding risks.

In summary, research suggests that this wearable device and behavioral support treatment is safe for people who have had a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to aid stroke recovery using a wearable device combined with behavioral support. Unlike standard therapies that focus on physical rehabilitation exercises, the movement variability group uses a smartwatch app to monitor and increase movement variability, which could lead to enhanced mobility and adaptability. Additionally, the control group focuses on increasing active movement time, offering insights into how simple movement tracking might improve stroke rehabilitation. This trial could reveal new strategies to enhance recovery by leveraging technology and personalized behavioral goals.

What evidence suggests that this wearable device and behavioral support are effective for improving upper extremity function in stroke patients?

Research shows that wearable devices with support can help stroke patients improve arm movement. In this trial, participants in the "Movement Variability" group will use a smartwatch app that records movement variability, aiming to increase their total movement variability. Studies have found that devices like smartwatches help monitor and encourage more varied movements in the affected arm. This feedback and guidance link to better recovery. Meanwhile, the "Active Time (Control)" group will receive feedback on active time, focusing on increasing their total movement time. Wearable tech can also track important health factors to help prevent future strokes. Combining technology with rehabilitation exercises motivates patients and improves their progress. ^{2 3 4 6 7}

Who Is on the Research Team?

David Reinkensmeyer, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 85 who have had a stroke at least six months ago, resulting in one-sided weakness. They must be able to move blocks in a test but still show some impairment compared to their unaffected arm. People with major depression or very high depression scores cannot join.

Inclusion Criteria

I am between 18 and 85 years old.

I do not have major depression according to DSM V or my depression score is low.

I can move at least 3 blocks in the Box and Block Test, but my affected arm performs at least 5% worse than my unaffected arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral support and feedback from a wearable device to improve arm use

9 weeks

Initial Visit, First follow up, Second follow up

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Device and Behavioral Support

Trial Overview The study tests if using a smartwatch app that tracks and encourages arm movement, along with motivational interviews, can help improve the use of arms in those who've had a stroke. It's set up as an initial test comparing different approaches.

How Is the Trial Designed?

Group I: Movement Variability Experimental Treatment 2 Interventions

The movement variability group will have a smartwatch app that records movement variability. Their movement goal will be centered on increasing their total movement variability as measured by the watch.

Group II: Active Time (Control) Placebo Group 2 Interventions

This group will only receive active-time feedback (the number of minutes and hours moving the upper extremity). Their goal will focus on increasing their total movement time.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04997408

Effectiveness of a Wearable Device-based Assisted Post ... Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6862815/

Wearable technology in stroke rehabilitation The present review aims to provide an overview of wearable sensors used in stroke rehabilitation research, with a particular focus on the upper extremity.

3. ahajournals.org ahajournals.org/do/10.1161/blog.20241028.65867

World Stroke Day: Wearable Technology in Global ... Wearables enable remote monitoring and detection of stroke risk factors, including blood pressure, blood flow dynamics, cholesterol levels, sleep apnea, pulse ...

4. mdpi.com mdpi.com/1424-8220/25/16/5204

Feasibility of Wearable Devices for Motivating Post-Stroke ... This study confirms the feasibility and potential clinical benefit of supplementing post-stroke rehabilitation with sensor-augmented exercises provided by the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0303846724005766

Integrating AI-driven wearable devices and biometric data ... For stroke survivors, wearable devices offer the potential to play a crucial role in recovery and the prevention of secondary strokes [45].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11468635/

Improving patient outcomes in acute and subacute stroke ... This study evaluated the combination of a wearable device-assisted system (WEAR) and conventional therapy for post-stroke rehabilitation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11927009/

Enhancing safety monitoring in post-stroke rehabilitation ... This study explores functional mobility in post-stroke individuals using wearable technology to quantify movement smoothness—an indicator of ...