Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT02896348

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

Led by Spaulding Rehabilitation Hospital · Updated on 2026-05-06

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic or hemorrhagic stroke at least 6 months prior to study enrollment
  • Moderate upper-extremity hemiparesis with Fugl-Meyer Assessment score between 21 and 55 out of 66
  • Ability to extend at least 2 fingers in the affected hand by 10 degrees at any joint
  • Pain-free passive range of motion of at least 50% in all joints below the elbow
Not Eligible

You will not qualify if you...

  • Cognitive impairment preventing following instructions or sustaining attention for more than 10 minutes
  • Current participation in an upper-extremity therapy program
  • Botox injections in the affected arm in the last 3 months or planned before study end
  • Aphasia limiting comprehension and treatment completion
  • More than moderate impairments in sensation, range of motion, or pain limiting therapy participation
  • Increased muscle tone with Modified Ashworth Scale score of 3 or higher
  • Previous diagnosis of dementia or neurological diseases other than stroke
  • History of seizure disorder or seizure within the last 6 months
  • Other conditions affecting function of the stroke-affected upper limb
  • Severe pain in the stroke-affected upper limb
  • Terminal illness with expected survival less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

K

Kathy Piela, PT, DPT

CONTACT

M

Motion Analysis Laboratory

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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