NCT06787729

At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.

Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is: Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living? The study is designed so each participant serves as their own control. Researchers will compare information from the baseline, intervention, and retention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm. Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.

Detailed description

To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention)-A (Retention) or Reversal Design. The A-B-A design allows for an analysis of the effects of the introduction and subsequent removal of the intervention elements, while providing all participants an opportunity to experience the novel intervention components. During the baseline phase (week 0 - week 2), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 14 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes. During the intervention phase (week 2 - week 6), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 4 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 3 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions. During the retention phase (week 6 - week 8), participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 2 weeks. However, the mobile intervention and clinician interactions (i.e., weekly Zoom calls) will be removed, while participants continue to wear sensors to examine the effects of withdrawing feedback. Clinical assessments will be completed after enrollment and following each phase.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	mHealth	The experimental design is composed of three phases: baseline, intervention, and retention. During the first two weeks (baseline), subjects will wear sensors, but no additional features (e.g., feedback, goal-setting, and weekly Zoom calls with clinicians) will be provided. For the next four weeks (intervention), subjects will wear sensors and have access to all intervention features, including weekly Zoom calls and goal-setting with clinicians. They will be encouraged to use the more impaired arm as much as possible. In the final two weeks (retention), the mobile intervention and clinician interactions will be removed, while subjects continue to wear sensors to examine the effects of withdrawing feedback.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-01-22
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States