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

Description

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.

Conditions

Stroke, Hemiparesis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Boston

Spaulding Rehabilitation Hospital, Boston, Massachusetts, United States, 02129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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;

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spaulding Rehabilitation Hospital,

Paolo Bonato, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

2026-12