RECRUITING

EMG Controlled Device in Acute Rehabilitation After Acute Stroke

Conditions

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

Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Official Title

Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke

Quick Facts

Study Start:2020-10-07
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04599036

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:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans over 18 years of age
  2. * 2 days to 6 months since the onset of ischemic stroke
  3. * Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device.
  4. * Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the Myopro software
  5. * MAS score 3 for the biceps, triceps, supinators and pronators of the impaired arm
  6. * Able to read and comprehend the English language
  7. * Able to follow directions
  8. * Medically and psychologically stable.
  1. * Previous strokes affecting motor function on the opposite side.
  2. * Fugl-Meyer score of 2 on the following 3 items:
  3. * Shoulder subluxation, pain or dislocation
  4. * Shoulder passive range of motion \< 45 degrees in flexion and abduction
  5. * Fixed upper limb contractures on the impaired arm and hand
  6. * Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
  7. * Skin rash or open wound on impaired arm
  8. * Involuntary movements of the impaired arm
  9. * Pacemaker or other implanted devices
  10. * Metal in the skull
  11. * Claustrophobia, or inability to operate the MRI patient call button
  12. * Past history of seizures
  13. * Family history of medication refractory epilepsy
  14. * Chronic sleep deprivation, ongoing untreated sleep disorder
  15. * Pregnancy or pregnancy planning during the study period
  16. * Currently taking medications or substances that lower the threshold for onset of seizure.
  17. * Inability to understand English

Contacts and Locations

Study Contact

Ahlam Salameh, PhD MSc
CONTACT
(216) 791-3800
Ahlam.Salameh@va.gov
Holly B Henry
CONTACT
(216) 791-3800
holly.henry@va.gov

Principal Investigator

Ahlam Salameh, PhD MSc
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH

Study Locations (Sites)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Ahlam Salameh, PhD MSc, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

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 Date2020-10-07
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2020-10-07
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke