Home-based retraining of hand function for stroke survivors using a new device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the usability and effectiveness of the SynPhNe device, designed for home use, in improving hand function among chronic stroke survivors. Participants will be randomly assigned to either use the SynPhNe system at home or receive conventional lab-based therapy. The device, which includes a forearm component and a head cap for monitoring brain activity, aims to provide feedback during motor tasks to enhance rehabilitation outcomes. The study will last up to 12 weeks and involve a total of 22 therapy sessions, combining both home and lab-based exercises.

Why it matters

Who can join: the full rules

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;

Where it's running

• Spaulding Rehabilitation Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Paolo Bonato, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Kathy Piela, PT, DPT
• Email: kpiela@mgb.org
• Phone: 6179526388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.