Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Str… (NCT02896348) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
United States40 participantsStarted 2025-02-26
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
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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;