Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Samsung Electronics
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Updated on 19 February 2024
See if I qualify
stroke
mini-mental state examination
chronic stroke
chronic cerebrovascular accident

Summary

A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and chronic stroke.

Details
Condition Cerebrovascular accident, Chronic Stroke
Age 18years - 85years
Treatment Samsung GEMS-H
Clinical Study IdentifierNCT04285060
SponsorSamsung Electronics
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

-days post stroke
Age: 18-85 Years
Initial gait speed of 0.4 m/s and 0.8 m/s
Adequate cognitive function (MMSE score >17)
Ability to walk at least 10m with maximum 1 person assist
Physician approval for patient participation
Able to safely fit into device specifications and tolerate minimum assistance

Exclusion Criteria

days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
months post coronary artery bypass graft (CABG) or cardiac valve procedure
Severe osteoporosis as indicated by physician medical clearance
Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
Pregnancy
Uncontrolled hypertension
Lower extremity fracture
Modified Ashworth Spasticity 3 in hip flexor or extensor
Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
History of: major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness
Participating in any other structured outpatient, home health physical therapy program, or another clinical trial that according to the Principal Investigator is likely to affect study outcome or confound results
TMS-Specific Exclusion Criteria
Pacemakers, metal implants in the head region
History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
Medications that lower seizure threshold
History of concussion in last 6 months
Clear my responses
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