Status:

RECRUITING

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

Lead Sponsor:

Spaulding Rehabilitation Hospital

Collaborating Sponsors:

BioSensics

MGH Institute of Health Professions

Conditions:

Stroke

Stroke Sequelae

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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 Inter...

Detailed 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 subacute stroke survivors. The Inter...

Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
  • 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;
  • Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
  • Diagnosis of other neurological disease; (i.e., Parkinson's disease, multiple sclerosis, ...);
  • 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;
  • Brainstem and cerebellar stroke.

Key Trial Info

Start Date :

August 8 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2026

Estimated Enrollment :

88 Patients enrolled

Trial Details

Trial ID

NCT06797154

Start Date

August 8 2025

End Date

August 31 2026

Last Update

November 28 2025

Active Locations (1)

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1

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States, 02129