No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Spaulding Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for people who have had a stroke at least 6 months ago and have difficulty using their affected hand. Participants will use a device at home to help improve their hand movement compared to standard therapy.
Are You a Good Fit for This Trial?
Rules you outCognitive impairmentDementiaPast neurological diseasesSeizure disorder
You may be able to join if
I have had a stroke at least 6 months ago.
I have moderate difficulty using my affected hand.
I can extend at least 2 fingers in my affected hand by 10 degrees.
You may not be able to join if
I have problems with my memory that make it hard to follow instructions.
I am currently in another therapy program for my arm.
I have had Botox injections in my affected arm in the past 3 months.
I have difficulty understanding and following instructions.
I have severe pain in my affected arm.
I have a history of a seizure in the last 6 months.
I have been diagnosed with dementia.
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 goal of this study is to:
1. Assess the usability of the SynPhNe device in a home environment.
2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
* Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
* Ability to extend at least 2 fingers in the affected hand 10 degrees at…
Inclusion Criteria:
* Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
* Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
* Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.
Exclusion Criteria:
* Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
* Current participation in upper-extremity therapy program;
* Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;
* Aphasia sufficient to limit comprehension and completion of the treatment protocol;
* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
* Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale;
* Previous diagnosis of dementia;
* Previous diagnosis of neurological diseases other than Stroke;
* History of seizures disorder and/or a seizure occuring within the last 6 months;
* Other conditions affecting function of the stroke affected upper limb;
* Severe pain in the stroke affected upper limb;
* Terminal diseases with expected survival \<1 year;
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