NCT06797154 A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
| NCT ID | NCT06797154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2025-08-08 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
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.
Contact & Investigator
Paolo Bonato, PhD
PRINCIPAL INVESTIGATOR
Spaulding Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT06797154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797154 currently recruiting?
Yes, NCT06797154 is actively recruiting participants. Contact the research team at pbonato@partners.org for enrollment information.
Where is the NCT06797154 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06797154 clinical trial?
NCT06797154 is sponsored by Spaulding Rehabilitation Hospital. The principal investigator is Paolo Bonato, PhD at Spaulding Rehabilitation Hospital. The trial plans to enroll 88 participants.
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