At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.
Part of paid clinical trials in Charlestown, Massachusetts.
- Sponsor
- Spaulding Rehabilitation Hospital
- Study ID
- NCT06787729
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- mHealth — DEVICEThe experimental design is composed of two phases: baseline and intervention. During the first week (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 three 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.
Study Details
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 and intervention 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.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: mHealth InterventionMembers of this group will receive the wearable sensors and mHealth smartphone application.
Primary Outcome Measure
Motor Activity Log - Amount of Use [ Time Frame: Week 0, Week 1, Week 4 ]
Central Contacts
- Kathy Piela, PT, DPT617-952-6388
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Spaulding Rehabilitation Hospital, Motion Analysis Laboratory | Charlestown | Massachusetts | 02474 | Paolo Bonato, PhD (PRINCIPAL_INVESTIGATOR) |
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