No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
Spaulding Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for people who have had a stroke and have difficulty using one arm. Participants will use a device called StrokeWear along with a home exercise plan for 6 months.
Are You a Good Fit for This Trial?
Rules you outParkinson's diseaseMultiple sclerosis
You may be able to join if
I am 18-85 years old.
I had a stroke at least 6 months ago.
I have weakness in one arm.
I can understand instructions.
I can use a tablet or smartphone.
You may not be able to join if
I have severe muscle stiffness that makes moving my arm unsafe.
I have major vision problems.
I have open wounds or recent fractures in my arm.
I am enrolled in another arm rehabilitation program.
I have other serious neurological diseases.
I do not understand English.
I had Botox in my arm recently.
I have problems moving my arm due to pain.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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-Mey…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.