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NCT02896348Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
18 Aug 2016
Start date
26 Feb 2025
Primary completion date
31 Dec 2026
Lead sponsor
Spaulding Rehabilitation Hospital
Diseases
Stroke
NCT number
NCT02896348

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 26 Feb 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
  • Previous diagnosis of dementia;
  • Previous diagnosis of neurological diseases other than Stroke;

Other illness

  • Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
  • 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;

Other

  • Aphasia sufficient to limit comprehension and completion of the treatment protocol;
  • Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale;

Who the study is looking for

  • 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.

Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Spaulding Rehabilitation Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.