StrokeWear for Chronic Stroke Recovery

Palo Alto (17 mi)

Overseen byPaolo Bonato, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Spaulding Rehabilitation Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 chronic 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

This trial is for chronic stroke survivors aged 18-85 with mild to moderate arm weakness from a stroke that happened between 6 months and 5 years ago. They must be able to understand the study, use a tablet or smartphone, and not have severe spasticity, visual impairments preventing app use, other neurological diseases, severe proprioceptive deficits, recent fractures or wounds in the affected arm, current enrollment in another upper extremity rehab program.

Inclusion Criteria

I can understand and follow study instructions well.

I am between 18 and 85 years old.

I have moderate weakness in one arm.

Exclusion Criteria

I am currently in a rehabilitation program for my upper extremity.

I have severe muscle stiffness that makes it hard to move my arms safely.

I have severe arm pain or injuries that limit my movement.

I have been diagnosed with a neurological condition like Parkinson's or multiple sclerosis.

I have severe difficulty feeling vibrations, as confirmed by a therapist.

I have had a stroke affecting my brainstem or cerebellum.

I do not have open wounds, recent fractures, fragile skin, or infections in my upper body.

Treatment Details

The trial is testing StrokeWear system combined with home motor and behavioral interventions against usual care involving a home-exercise plan. Participants are randomly placed into either group for six months to see if StrokeWear improves their ability to use their affected arm in daily life.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: StrokeWear Motor and Behavioral InterventionExperimental Treatment1 Intervention

Group II: Usual CarePlacebo Group1 Intervention