Smartwatch-Style sensor aims to rehabilitate Stroke-Weakened arms
NCT ID NCT05626894
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests a wrist-worn sensor system called StrokeWear, combined with goal-setting and daily action planning, to encourage stroke survivors to use their weaker arm more during everyday activities. The study enrolls 32 chronic stroke survivors who will either use the system for 6 months or follow a standard home exercise plan. The goal is to see if the device and coaching improve arm movement and real-world use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- StrokeWear wrist sensor and behavioral intervention
- What this could lead to
- If successful, this could offer a practical home-based tool to improve arm function and daily use for chronic stroke survivors.
- What could go wrong
- This is a small early-phase trial with only 32 participants, so results may not apply broadly. The intervention requires consistent patient engagement, which may be challenging.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 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; * Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study) * 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 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; * Brainstem and cerebellar stroke.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spaulding Rehabilitation Hospital Boston
RECRUITINGBoston, Massachusetts, 02129, United States
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