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Taking people in United StatesPhase 2

Wrist Sensor Device to Encourage Arm Use at Home After Stroke

Tests a wrist sensor system with home motor training in adults with chronic stroke.

Plain-language title generated from the registry record
Registry title: Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

Key facts

Where
Boston, United StatesSee the site
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Source: NCT05626894, who can take part

Where in United States

  • Spaulding Rehabilitation Hospital BostonBoston, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Spaulding Rehabilitation Hospital
Trial code
NCT05626894
Record updated
28 November 2025
Original description
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 chronic 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).Read full original descriptionShow less

A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors

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 chronic 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).

Inclusion: Male or female, 18-85 years of age at the time of enrollment; Anterior circulation ischemic stroke at least 6 months and up to 5 years prior to study enrollment; Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45; Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command); Being familiar and comfortable with the use of a tablet or smartphone.

Exclusion: Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see feedback on the app screen (as assessed with the star cancellation test); Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist; Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...); Brainstem and cerebellar stroke; Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks; Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study); Upper-extremity orthopedic injuries or severe pain resulting in movement limitations; Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening as assessed by the study therapist; Not understanding spoken or written English; Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline; Contralateral motor deficits as assessed by clinical examination.

ClinicalTrials.gov NCT05626894