Back to search results

Wrist Wearable Sensor System for Stroke Recovery

This study is testing a new system called StrokeWear to help people who have had a stroke recover movement in their arm and hand (hemiparesis). The StrokeWear system uses a wrist sensor and includes behavioral strategies like goal setting and activity planning. You might be able to join if you are between 18 and 85 years old, had an ischemic stroke (a stroke caused by a blood clot) 1 to 6 months ago, and have some weakness in one arm. The study will look at how much you use your affected arm and hand, and how much your arm movement improves over 6 months. The current recruitment status is unclear.

Study design
This is a randomized clinical trial with 88 planned participants. It compares the StrokeWear system with usual care and a sham device.
What's involved
You would have 4 study visits: one for screening, and three evaluation visits at baseline, 3 months, and 6 months. You would also have weekly, bi-weekly, or monthly coaching sessions depending on your group and the study phase.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes up to 6 months, which indicates the follow-up period.

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

NCT06797154

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

Recruiting
NAAges 18–85InterventionalTreatment
Spaulding Rehabilitation Hospital
~88 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:StrokeWear Behavioral InterventionUsual Care + Sham

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

NCT06797154

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, 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.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

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