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

STATUS

Recruiting
participants needed

60
sponsor

Samsung Electronics

Send

Updated on 19 February 2024

See if I qualify

stroke

mini-mental state examination

chronic stroke

chronic cerebrovascular accident

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.

Details

Condition	Cerebrovascular accident, Chronic Stroke
Age	18-85 years
Treatment	Samsung GEMS-H
Clinical Study Identifier	NCT04285060
Sponsor	Samsung Electronics
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	-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
	days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

stroke

mini-mental state examination

chronic stroke

chronic cerebrovascular accident

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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