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

Samsung

Status: Unknown

Conditions: Stroke; Chronic Stroke

Treatments: Device: Samsung GEMS-H

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04285060

00210372

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 30-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

• ≤90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
• ≤ 6 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Training Group

Experimental group

Description:

All participants are assigned to the training group with the Samsung GEMS-H.

Treatment:

Device: Samsung GEMS-H