RecruitingNot ApplicableNCT02896348

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

Sponsor

Spaulding Rehabilitation Hospital

Enrollment

40 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Hemiparesis Stroke

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.

Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria12

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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Interventions

DEVICESynPhNe platform

SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performing the exercises. The computer software adopts the appropriate difficulty level, speed and duration of the exercise depending on brain and muscle status to minimize fatigue.

OTHERConventional therapy

Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it.