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

Not Applicable

• Conditions: Chronic Stroke; Stroke
• Interventions: Device: Samsung GEMS-H

• Registration Number: NCT04285060
• Lead Sponsor: Samsung Electronics

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 participants with sub-acute and chronic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training Group	Samsung GEMS-H	All participants are assigned to the training group with the Samsung GEMS-H.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States