AzTrials
AzTrials

StrokeNCT02843828

Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults

A study testing gait rehabilitation with Samsung Hip Assist v1 and gait rehabilitation without Samsung Hip Assist v1 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
Search all trials

Trial summary

The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients. Read more about this study

Who is it for?
Ages 50 to 84 years
Conditions the study is for
Stroke, Healthy
What is being tested?
gait rehabilitation with Samsung Hip Assist v1 and gait rehabilitation without Samsung Hip Assist v1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSouth Korea
Study dates
2 Jan 2016to 1 Sep 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 50 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
  • High levels of physical performance (SPPB > 7)
  • Subject is willing to be randomized to the control group or the treatment group
Show all 13Show fewer
  • Stroke
  • Age: between 50 and 84 years
  • ≥ 3 months post stroke
  • Ability to walk at least 10m regardless of assist devices
  • Adequate gait function (FAC > 3)
  • Physician approval for patient participation
  • Subject is willing to be randomized to the control group or the treatment group

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

Official title: Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults

The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.

Read the detailed description

Randomized, two treatment groups

Number of Subjects : 54 subjects (n=27 per group)

Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session

Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session

Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA).

Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Tinetti performance oriented mobility assessment (POMA), Korean version Modified Bathel index (K-MBI), Modified Rankin Scale (MRS), Functional Ambulation Classification (FAC), Fugl-Meyer assessment for lower extremity (FMA), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

Conditions
Stroke, Healthy
Being tested
gait rehabilitation with Samsung Hip Assist v1, gait rehabilitation without Samsung Hip Assist v1
Keywords
Exoskeleton Device, elderly, stroke, gait rehabilitation
Medical subject headings
Stroke

What participants receive

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

  • gait rehabilitation with Samsung Hip Assist v1Device

    Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

  • gait rehabilitation without Samsung Hip Assist v1Other

    Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

Study groups in NCT02843828
Study groupRoleWhat they receive
Samsung Hip Assist v1Experimentalgait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
Receives: Device: gait rehabilitation with Samsung Hip Assist v1
Conventional gait trainingActive comparatorgait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
Receives: Other: gait rehabilitation without Samsung Hip Assist v1

What is being measured

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

  1. 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: session 0 (initial visit); session 11 (at approximately 4 weeks)

Secondary outcomes (9)

  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: session 0 (initial visit); session 11 (at approximately 4 weeks)

  2. Tinetti performance oriented mobility assessment (POMA)

    Task-oriented outcome measure that assesses gait and balance ability is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B).

    Measured: session 0 (initial visit); session 11 (at approximately 4 weeks)

  3. Modified Bathel index (MBI)

    The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.

    Measured: session 0 (initial visit); session 11 (at approximately 4 weeks)

  4. 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: session 0 (initial visit); session 11 (at approximately 4 weeks)

  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: session 0 (initial visit); session 11 (at approximately 4 weeks)

  6. Fugl-Meyer assessment for lower extremity (FMA)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

    Measured: session 0 (initial visit); session 11 (at approximately 4 weeks)

  7. 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: session 0 (initial visit); session 11 (at approximately 4 weeks)

  8. 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: session 0 (initial visit); session 11 (at approximately 4 weeks)

  9. Range of Motion (ROM)

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

    Measured: session 0 (initial visit); session 11 (at approximately 4 weeks)

Timeline

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

  1. First posted26 Jul 2016 (estimated)
  2. Study start2 Jan 2016
  3. Primary completion30 Aug 2017
  4. Study completion1 Sep 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843828
Sponsor's protocol ID
2015-05-013-003
Status last verified
Apr 2019
First submitted
14 Jul 2016
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee HJ, Lee SH, Seo K, Lee M, Chang WH, Choi BO, Ryu GH, Kim YH. Training for Walking Efficiency With a Wearable Hip-Assist Robot in Patients With Stroke: A Pilot Randomized Controlled Trial. Stroke. 2019 Dec;50(12):3545-3552. doi: 10.1161/STROKEAHA.119.025950. Epub 2019 Oct 18.

    PubMed 31623545

  • Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.

    PubMed 29183379

Questions about this trial

What is this clinical trial studying?

A study testing gait rehabilitation with Samsung Hip Assist v1 and gait rehabilitation without Samsung Hip Assist v1 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 13 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 10 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?

Change in 10 meter walk test from baseline in gait speed (time frame: session 0 (initial visit); session 11 (at approximately 4 weeks)). 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 NCT02843828, which also lists 2 linked publications.

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 10 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in