StrokeNCT03341065
Comparisons of Two Types of Robot Assisted Gait Training
A study testing exoskeleton type robot and end-effector type robot in people with Stroke and Robot Assisted Gait Training, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke, Robot Assisted Gait Training
- What is being tested?
- exoskeleton type robot and end-effector type robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic patients secondary to first cerebrovascular accidents
- Ankle dorsiflexor strength: medical research council scale 2 or 3
- Functional ambulation category score 3
Who cannot join
- History of surgery of affected lower limb
- Fracture of affected lower limb
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, 142884
Joon-Ho Shin, MS
Joon-Ho Shin, MS
About this study
Official title: Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
- Conditions
- Stroke, Robot Assisted Gait Training
- Being tested
- exoskeleton type robot, end-effector type robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exoskeleton type robotDevice
end-effector type robotDevice
| Study group | Role | What they receive |
|---|---|---|
| exoskeleton type robot | Experimental | exoskeleton type robot assisted gait training (Lokomat orthosis) Receives: Device: exoskeleton type robot |
| end-effector type robot | Experimental | end-effector type robot assisted gait training (G-EO system) Receives: Device: end-effector type robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Range of motion of ankle joint at 4 weeks
ankle joint motion of sagittal plane during gait
Measured: 4 weeks from baseline
Secondary outcomes (12)
Trunk impairment scale
Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination, and the maximum score on the subscales are 7, 10, and 6 points, repectively. The total score ranges from 0 to 23 points, a higher score indicating a better trunk performance.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Berg Balance Scale
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) floolwing the guidelines of the test develpers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
10m walk test
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Korean version of Falls efficacy scale
Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of hip joint
Hip joint motion of sagittal plane during gait
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of knee joint
knee joint motion of sagittal plane during gait
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of ankle joint
ankle joint motion of sagittal plane during gait
Measured: Baseline, 8 weeks from baseline
Electromyography of lower extremities
Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Plantar pressure
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Step length, time
Step length, stance time, swing time, and stride time during gait
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Functional Ambulation Category
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341065
- Sponsor's protocol ID
- NRC-2016-01-006
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03341065
- Acronym / sponsor ID
- NRC-2016-01-006
- Conditions
- Stroke, Robot Assisted Gait Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Nov 2017 (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.
Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exoskeleton type robot | Experimental | Device: exoskeleton type robotexoskeleton type robot assisted gait training (Lokomat orthosis) |
| end-effector type robot | Experimental | Device: end-effector type robotend-effector type robot assisted gait training (G-EO system) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemiplegic patients secondary to first cerebrovascular accidents
- Ankle dorsiflexor strength: medical research council scale 2 or 3
- Functional ambulation category score 3
Key exclusion criteria (2 listed)
- History of surgery of affected lower limb
- Fracture of affected lower limb
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 |
|---|---|---|
| exoskeleton type robot | Device | exoskeleton type robot |
| end-effector type robot | Device | end-effector type robot |
Primary outcome
Change of Range of motion of ankle joint at 4 weeks
Time frame: 4 weeks from baseline
ankle joint motion of sagittal plane during gait
12 secondary outcomes
Trunk impairment scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Berg Balance Scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
10m walk test
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Fugl-Meyer Assessment
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Korean version of Falls efficacy scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of hip joint
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of knee joint
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of ankle joint
Time frame: Baseline, 8 weeks from baseline
Electromyography of lower extremities
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Plantar pressure
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Step length, time
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Functional Ambulation Category
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Site of the present studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exoskeleton type robot and end-effector type robot in people with Stroke and Robot Assisted Gait Training, run by National Rehabilitation Center, Seoul, Korea 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 3 inclusion and 2 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 17 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon-Ho Shin, MS (82-2-901-1884, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Range of motion of ankle joint at 4 weeks (time frame: 4 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.