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StrokeWear System for Arm Use After Stroke

This study is testing a new wrist sensor system called StrokeWear to help people who have had a stroke improve the use of their arm. If you join, you would either use the StrokeWear system with special exercises and coaching, or you would receive usual care with a home exercise plan. Researchers want to see if the StrokeWear system helps improve arm movement and how much you use your arm in daily life over 6 months. To be eligible, you need to be between 18 and 85 years old, have had an ischemic stroke (a stroke caused by a blood clot) at least 6 months ago, and have some arm weakness (hemiparesis). The current recruitment status is unclear.

Study design
This is a randomized study with 32 participants. It compares the StrokeWear system to usual care.
What's involved
You would have 4 evaluation visits over 6 months. If in the intervention group, you would also have weekly, bi-weekly, or monthly coaching sessions.
Compensation
Not stated in the trial record.
Follow-up
Your arm function will be assessed at 3 and 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05626894

Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

Recruiting
PHASE2Ages 18–85InterventionalTreatment
Spaulding Rehabilitation Hospital
~32 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:StrokeWear Motor and Behavioral InterventionUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Motor Activity Log-Amount of Use
Measured over Change from baseline Motor Activity Log-Amount of Use score at 6 months
+2 more outcomes measured

Conditions

Stroke
Stroke Sequelae
Hemiparesis;Poststroke/CVA

Explore related trials

HemiparesisStroke

NCT05626894

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Spaulding Rehabilitation Hospital Boston

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Paolo Bonato, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

Who to contact

Paolo Bonato, PhD
[email protected]
617-952-6319
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Motor Activity Log-Amount of UseChange from baseline Motor Activity Log-Amount of Use score at 6 months

    Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)

  • Change in Fugl-Meyer Upper-ExtremityChange from baseline Fugl-Meyer Upper-Extremity score at 6 months

    Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)

  • Change in Upper-Extremity Activity CountsChange from baseline Upper-Extremity Activity Counts score at 6 months

    Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers