Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors

Launched by SPAULDING REHABILITATION HOSPITAL · Sep 9, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a device called SynPhNe, which is designed to help stroke survivors improve their hand function while using it at home. The main goals are to see how easy it is for people to use this device in their daily lives and to find out if it can help improve hand movement more effectively than regular therapy alone. The study is open to both men and women aged between 18 and 90 who have had a stroke at least six months prior and experience moderate difficulty using their affected arm.

To be eligible for this trial, participants should be able to move at least two fingers on their affected hand and have some level of hand movement, without significant pain. However, people with certain conditions, like severe cognitive impairment or those currently receiving similar therapy, won't be able to join. If you participate, you can expect to use the SynPhNe device at home and be part of a study that could help improve recovery options for stroke survivors in the future.

Gender

ALL

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 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;