Clinical trial NCT04285060: Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
Official title: Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Chronic Stroke
Keywords: Stroke
Exoskeleton
Lead sponsor: Samsung Electronics
Sponsor class: INDUSTRY
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2020-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of device related adverse events
timeFrame: Duration of study participation (estimated 6 months)
measure: 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks)
Secondary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks)
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks)
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks)
Other outcomes:
measure: Incidence of device malfunctions
timeFrame: Duration of study (estimated 12 months)
measure: ActiGraph activity monitor
timeFrame: Duration of study participation (estimated 4 months)
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks)
measure: 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 10 Meter Walk Test (Fastest walking speed) (10MWT-FS)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 6 Minute Walk Test (6MWT) with the device
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
measure: 5 Times Sit to Stand Test (5xSST)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Gait analysis using a gait mat
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Manual Muscle Testing (MMT)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Modified Ashworth Test (MAS)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Passive Range of Motion (PROM)
timeFrame: Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Modified Falls Efficacy Scale (mFES)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Activities-specific and Balance Confidence Scale (ABC)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Stoke Impact Scale (SIS)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Stroke Specific Quality of Life (SSQoL)
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
measure: Oxygen Consumption using Cosmed K4b2
timeFrame: Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: