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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorSpaulding Rehabilitation Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SynPhNe platform
  • Conventional therapy

Treatment groups

40 Participants
are divided into 2 treatment groups