Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
Recruiting now · Not applicable
Conditions studied: Stroke, Hemiparesis
In brief
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.
Key facts
- Study ID
- NCT02896348
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 40
- Starts
- 2025-02-26
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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