Status:
UNKNOWN
Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
Lead Sponsor:
Samsung Electronics
Collaborating Sponsors:
Shirley Ryan AbilityLab
Conditions:
Stroke
Chronic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 part...
Eligibility Criteria
Inclusion
- ≥ 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
- ≤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
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04285060
Start Date
February 12 2020
End Date
December 1 2021
Last Update
September 27 2021
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611