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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study

Conditions
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Stroke, Chronic Stroke

Intervention / Treatment
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* Device: Samsung GEMS-H


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training Group<br>All participants are assigned to the training group with the Samsung GEMS-H. | Device: Samsung GEMS-H<br>* Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device related adverse events | Safety will be assessed by the number of device related adverse events throughout the duration of the study | Duration of study participation (estimated 6 months) | 
| 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) | Change in self-selected walking speed measured without the device | Baseline, Post-Intervention (estimated 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test (6MWT) | Change in walking endurance measured without the device | Baseline, Post-Intervention (estimated 8 weeks) | 
| Berg Balance Scale (BBS) | Changes in functional balance measured without the device | Baseline, Post-Intervention (estimated 8 weeks) | 
| Functional Gait Assessment (FGA) | Change in functional balance measured without the device | Baseline, Post-Intervention (estimated 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exoskeleton