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NCT06797154Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
88 (estimated)
First submitted
21 Jan 2025
Start date
8 Aug 2025
Primary completion date
30 Jun 2026
Lead sponsor
Spaulding Rehabilitation Hospital
Diseases
Stroke
NCT number
NCT06797154

What you commit to

  • Study type: Interventional
  • Planned participants: 88
  • From 8 Aug 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 the feedback on the app screen (as assessed with the Mesulum cancellation test);
  • Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
  • Diagnosis of other neurological disease; (i.e., Parkinson's disease, multiple sclerosis, ...);
  • Brainstem and cerebellar stroke.

Other

  • Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
  • 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;
  • Not understanding spoken or written English;
  • Contralateral motor deficits as assessed by clinical examination;

Who the study is looking for

  • Male or female, 18-85 years of age at the time of enrollment
  • Anterior circulation ischemic stroke at least 1 month and no more than 6 months 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 3step command) ;
  • Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
  • SAFE score equal or greater than 5

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Spaulding Rehabilitation Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.