RECRUITING

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

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Conditions

StrokeHemiparesisRehabilitationHome-based

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02896348

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.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
  2. * Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
  3. * 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.
  1. * Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
  2. * Current participation in upper-extremity therapy program;
  3. * Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;
  4. * Aphasia sufficient to limit comprehension and completion of the treatment protocol;
  5. * No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
  6. * Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale;
  7. * Previous diagnosis of dementia;
  8. * Previous diagnosis of neurological diseases other than Stroke;
  9. * History of seizures disorder and/or a seizure occuring within the last 6 months;
  10. * Other conditions affecting function of the stroke affected upper limb;
  11. * Severe pain in the stroke affected upper limb;
  12. * Terminal diseases with expected survival \<1 year;

Contacts and Locations

Study Contact

Kathy Piela, PT, DPT
CONTACT
6179526388
kpiela@mgb.org
Motion Analysis Laboratory
CONTACT
6179526331

Principal Investigator

Paolo Bonato, PhD
PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital

Study Locations (Sites)

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

  • Paolo Bonato, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Hemiparesis
  • Stroke
  • Rehabilitation
  • Home-based

Additional Relevant MeSH Terms

  • Stroke
  • Hemiparesis