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StrokeNCT03048968

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

A study testing Gait, sit-to-stand movement, stair climbing and treadmill gait, Sit-to-stand movement and treadmill gait and gait enhancing mechatronic system (GEMS) in people with Stroke and Healthy, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to investigate the effects of the new wearable hip assist robot, gait enhancing and motivating system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and cortical activation in elderly adults and stroke… Read more about this study

Who is it for?
Ages 20 to 84 years
Conditions the study is for
Stroke, Healthy
What is being tested?
Gait, sit-to-stand movement, stair climbing and treadmill gait, Sit-to-stand movement and treadmill gait and gait enhancing mechatronic system (GEMS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
1 Mar 2017to 23 Oct 2017
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 20 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elderly adults
  • Age: between 65 and 84 years
  • elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
  • Ability to walk at least 10m regardless of assist devices
  • Stroke
  • Age: between 20 and 84 years
Show all 10Show fewer
  • ≥ 3 months post stroke
  • Ability to walk at least 10m regardless of assist devices
  • Adequate gait function (FAC > 3)
  • Physician approval for patient participation

Who cannot join

  • Elderly adults
  • History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
  • Severe visual impairment or dizziness that increases the risk of falls
  • Stroke
  • 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)
  • Advanced liver, kidney, cardiac, or pulmonary disease
Show all 9Show fewer
  • History of concussion in last 6 months
  • History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
  • Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

The purpose of this study was to investigate the effects of the new wearable hip assist robot, gait enhancing and motivating system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and cortical activation in elderly adults and stroke patients.

Read the detailed description

In elderly adults,

  1. Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA) and F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA) during 10m walking test.
  2. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
  3. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing.
  4. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

In stroke patients,

  1. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
  2. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Conditions
Stroke, Healthy
Being tested
Gait, sit-to-stand movement, stair climbing and treadmill gait, Sit-to-stand movement and treadmill gait, gait enhancing mechatronic system (GEMS), treadmill
Keywords
Exoskeleton Device, elderly, stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait, sit-to-stand movement, stair climbing and treadmill gaitProcedure or surgery

    Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system, surface electromyography (sEMG) and F-Scan Mobile system during 10m walking test. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

  • Sit-to-stand movement and treadmill gaitProcedure or surgery

    Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

  • gait enhancing mechatronic system (GEMS)Device

    Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS in elderly adults.

    Sit-to-stand movement and treadmill gait with GEMS and without GEMS in stroke patients.

  • treadmillDevice

    Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Study groups in NCT03048968
Study groupRoleWhat they receive
study group1: elderly adultsExperimentalGait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
Receives: Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait; Device: gait enhancing mechatronic system (GEMS); Device: treadmill
study group2: stroke patientsExperimentalSit-to-stand movement and treadmill gait with GEMS and without GEMS
Receives: Procedure: Sit-to-stand movement and treadmill gait; Device: gait enhancing mechatronic system (GEMS); Device: treadmill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cortical activation

    Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

    Measured: 30minutes

Secondary outcomes (7)

  1. Berg Balance Scale (BBS)

    The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed.

    Measured: 30minutes

  2. Fall Efficacy Scale (FES)

    Fall Efficacy Scale (FES) is a 10-item questionnaire designed confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all"), and the per item ratings are added to generate a summary total score.

    Measured: 20minutes

  3. Manual Muscle Test (MMT)

    Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.

    Measured: 20minutes

  4. Range of Motion (ROM)

    Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.

    Measured: 20minutes

  5. Functional Ambulation Classification (FAC)

    The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.

    Measured: 20minutes

  6. The modified Rankin Scale (mRS)

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    Measured: 20minutes

  7. Change in 10 meter walk test from baseline in gait speed

    Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

    Measured: 1hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion30 Sep 2017
  4. Study completion23 Oct 2017

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03048968
Sponsor's protocol ID
2016-07-093
Status last verified
Apr 2019
First submitted
6 Feb 2017
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee SH, Lee HJ, Shim Y, Chang WH, Choi BO, Ryu GH, Kim YH. Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. J Neuroeng Rehabil. 2020 Oct 29;17(1):145. doi: 10.1186/s12984-020-00777-0.

    PubMed 33121535

Questions about this trial

What is this clinical trial studying?

A study testing Gait, sit-to-stand movement, stair climbing and treadmill gait, Sit-to-stand movement and treadmill gait and gait enhancing mechatronic system (GEMS) in people with Stroke and Healthy, run by Samsung Medical Center at 1 site in South Korea.

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 10 inclusion and 9 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: finished, as of the sponsor's last update on 29 Apr 2019. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cortical activation (time frame: 30minutes). 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 NCT03048968, 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 29 Apr 2019.

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Clinical Trial NCT03048968 | AzTrials