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

NCT04285060 | Unknown DMC FDA Device

• 1 other identifier: 00210372
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Chronic Stroke

Keywords

Stroke; Exoskeleton

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 6 Minute Walk Test (6MWT)

  Baseline, Post-Intervention (estimated 8 weeks)

• Berg Balance Scale (BBS)

  Baseline, Post-Intervention (estimated 8 weeks)

• Functional Gait Assessment (FGA)

  Baseline, Post-Intervention (estimated 8 weeks)

Other Outcomes (23)

• Incidence of device malfunctions

  Duration of study (estimated 12 months)

• ActiGraph activity monitor

  Duration of study participation (estimated 4 months)

• Transcranial Magnetic Stimulation (TMS)

  Baseline, Post-Intervention (estimated 8 weeks)

Study Arms (1)

Training Group

EXPERIMENTAL

All participants are assigned to the training group with the Samsung GEMS-H.

Device: Samsung GEMS-H

Interventions

Samsung GEMS-H DEVICE

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.

Training Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• ≤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.
• 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

Sponsors & Collaborators

• Samsung Electronics: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Macaluso R, Giffhorn M, Prokup S, Cleland B, Lee J, Lim B, Lee M, Lee HJ, Madhavan S, Jayaraman A. Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation. J Neuroeng Rehabil. 2024 Jul 30;21(1):127. doi: 10.1186/s12984-024-01421-x.

  PMID: 39080666 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Arun Jayaraman, Ph.D.

CONTACT

+1-312-238-6875; ajayaraman@sralab.org

Kristen Hohl, DPT

CONTACT

+1-312-238-2640; khohl@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: February 12, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)