StrokeNCT04285060
Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
A study testing Samsung GEMS-H in people with Stroke and Chronic Stroke, run by Samsung Electronics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Chronic Stroke
- What is being tested?
- Samsung GEMS-H
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- ≤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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Arun Jayaraman, Ph.D., ajayaraman@sralab.org
About this study
Official title: 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.
- Conditions
- Stroke, Chronic Stroke
- Being tested
- Samsung GEMS-H
- Keywords
- Stroke, Exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung GEMS-HDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | All participants are assigned to the training group with the Samsung GEMS-H. Receives: Device: Samsung GEMS-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device related adverse events
Safety will be assessed by the number of device related adverse events throughout the duration of the study
Measured: 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
Measured: Baseline, Post-Intervention (estimated 8 weeks)
Secondary outcomes (3)
6 Minute Walk Test (6MWT)
Change in walking endurance measured without the device
Measured: Baseline, Post-Intervention (estimated 8 weeks)
Berg Balance Scale (BBS)
Changes in functional balance measured without the device
Measured: Baseline, Post-Intervention (estimated 8 weeks)
Functional Gait Assessment (FGA)
Change in functional balance measured without the device
Measured: Baseline, Post-Intervention (estimated 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start12 Feb 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Electronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285060
- Sponsor's protocol ID
- 00210372
- Status last verified
- Sep 2021
- First submitted
- 24 Feb 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39080666
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study
- ClinicalTrials.gov ID
- NCT04285060
- Acronym / sponsor ID
- 00210372
- Conditions
- Stroke, Chronic Stroke
- Keywords
- Stroke, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung ElectronicsIndustry (pharma, biotech, devices)
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Device: Samsung GEMS-HAll participants are assigned to the training group with the Samsung GEMS-H. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (16 listed)
- ≤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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samsung GEMS-HSubjects 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. | Device | Training Group |
Primary outcome
Incidence of device related adverse events
Time frame: Duration of study participation (estimated 6 months)
Safety will be assessed by the number of device related adverse events throughout the duration of the study
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Change in self-selected walking speed measured without the device
3 secondary outcomes
6 Minute Walk Test (6MWT)
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Berg Balance Scale (BBS)
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Functional Gait Assessment (FGA)
Time frame: Baseline, Post-Intervention (estimated 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 39080666Macaluso 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.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samsung GEMS-H in people with Stroke and Chronic Stroke, run by Samsung Electronics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arun Jayaraman, Ph.D. (+1-312-238-6875, ajayaraman@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device related adverse events (time frame: Duration of study participation (estimated 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.