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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Samsung GEMS-H Device Training in Older Adults

NCT05197127

Geriatrics

COMPLETED NA

The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults

NCT03048968

Stroke Healthy

COMPLETED NA

Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Patients With Chronic Stroke

NCT03326011

Gait Disorders, Neurologic Stroke

COMPLETED NA

Effects of Gait Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Stroke

NCT00530543

Stroke

UNKNOWN NA

Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

NCT03708016

Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Chronic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training Group

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

Group Type EXPERIMENTAL

Samsung GEMS-H

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No