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

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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 Identifier	NCT04285060
Sponsor	Samsung Electronics
Last Modified on	19 February 2024

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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

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