Recruiting

Samsung GEMS-H

Sponsor:

Samsung Electronics

Code:

NCT04285060

Conditions

Stroke

Chronic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Samsung GEMS-H

Study Details

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

Study ID

NCT04285060

Start date

Feb 12, 2020

Status verified date

Sep, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Training Group

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

Interventions

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.

Primary outcome measure

  • Incidence of device related adverse events [ Time Frame: Duration of study participation (estimated 6 months) ]
  • 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) [ Time Frame: Baseline, Post-Intervention (estimated 8 weeks) ]

Central Contacts and Locations

Central contacts

Arun Jayaraman, Ph.D.

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

Kristen Hohl, DPT

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

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Arun Jayaraman, Ph.D.

ajayaraman@sralab.org

More Information

Sponsor

Samsung Electronics

Last update posted

Sep 27, 2021

Last verified

Sep, 2021

Keywords

  • Stroke
  • Exoskeleton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Samsung Electronics on 2021-09-27.