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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion pushed from Jan 2027 to Jan 31, 2027
    • Study completion pushed from Jul 2027 to Jul 31, 2027
    • Start date changed from estimate of Apr 2026 to Apr 20, 2026
    v5
  2. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 59 words
    v4
  3. Notable Primary completion date: Jan 2026 to Jan 2027
    • Start date: Oct 2025 to Apr 2026
    • Study completion date: Jul 2026 to Jul 2027
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2025 to Oct 2025
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06787729
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: University of Massachusetts, Amherst, University of Maryland, College Park, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions
(from sponsor)
Stroke
Related terms Asthenia, Paresis, Stroke
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov