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A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 28, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Aug 8, 2025
    • Primary completion date: Feb 27, 2026 to Jun 30, 2026
    • Study completion date: May 27, 2026 to Aug 31, 2026
    • Interventions: StrokeWear Motor and Behavioral Intervention (Behavioral), Usual Care + Sham (Other) to StrokeWear Behavioral Intervention (Behavioral), Usual Care + Sham (Other)
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Trial Details
NCT Number NCT06797154
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
Related terms Stroke
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov