AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 85 YearsAllSpaulding Rehabilitation Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • StrokeWear Behavioral Intervention
  • Usual Care + Sham
๐Ÿ“

Where

1 site
Spaulding Rehabilitation Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy