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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Chronic Stroke
• Intervention / Treatment: Device: Samsung GEMS-H

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arun Jayaraman, Ph.D.; Phone Number: +1-312-238-6875; Email: ajayaraman@sralab.org
• Study Contact Backup: Name: Kristen Hohl, DPT; Phone Number: +1-312-238-2640; Email: khohl@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab
      • Contact: Arun Jayaraman, Ph.D.; Email: ajayaraman@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Training Group; All participants are assigned to the training group with the Samsung GEMS-H.

Device: Samsung GEMS-H; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device malfunctions	Device reliability will be assessed by the number of device malfunctions throughout the duration of the study	Duration of study (estimated 12 months)
ActiGraph activity monitor	Changes in average daily step count	Duration of study participation (estimated 4 months)
Transcranial Magnetic Stimulation (TMS)	Measure changes in descending corticospinal drive to the lower limb muscles	Baseline, Post-Intervention (estimated 8 weeks)
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)	Changes in self-selected walking speed measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
10 Meter Walk Test (Fastest walking speed) (10MWT-FS)	Changes in fastest walking speed measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device	Changes in self-selected walking speeds between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device	Changes in fastest walking speeds between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
6 Minute Walk Test (6MWT)	Changes in walking endurance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
6 Minute Walk Test (6MWT) with the device	Changes in walking endurance between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Berg Balance Scale (BBS)	Changes in functional balance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Functional Gait Assessment (FGA)	Change in functional balance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
5 Times Sit to Stand Test (5xSST)	Change in lower extremity strength measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Gait analysis using a gait mat	Changes in spatiotemporal parameters measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)	Changes in motor recovery measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Manual Muscle Testing (MMT)	Changes in leg strength measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Modified Ashworth Test (MAS)	Changes in leg spasticity measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Passive Range of Motion (PROM)	Changes in passive range of motion in leg joints measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Modified Falls Efficacy Scale (mFES)	Changes in perception of balance and stability	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Activities-specific and Balance Confidence Scale (ABC)	Changes in confidence in performing various ambulatory activities without falling	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Stoke Impact Scale (SIS)	Changes in the measure of the impact of stroke on overall physical and cognitive function	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Patient Health Questionnaire-9 (PHQ-9)	Changes in depression	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Stroke Specific Quality of Life (SSQoL)	Changes in the health-related quality of life	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Oxygen Consumption using Cosmed K4b2	Changes in metabolic energy expenditure	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)

Collaborators and Investigators

• Sponsor: Samsung Electronics
• Collaborators: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Exoskeleton
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 00210372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No