StrokeNCT02569190
Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
A study testing Walkbot in people with Stroke, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Walkbot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Mar 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke attack
- Within 3 months after stroke onset
- Supratentorial stroke
- Unilateral stroke
Who cannot join
- Bilateral stroke
- infratentorial stroke
- Cognitive disabilities or serious psychiatric illness.
- Difficulty in walking due to orthopedic problems.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Veterans Health Service Medical Center
Seoul, Gangdong-gu, 05368
About this study
Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.
Read the detailed description
This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.
- Conditions
- Stroke
- Being tested
- Walkbot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkbotDevice
Robot assisted gait training
| Study group | Role | What they receive |
|---|---|---|
| Walkbot | Experimental | Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all. Receives: Device: Walkbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention
Measured: at the first day of intervention and 8 weeks after the first day
Secondary outcomes (4)
Functional ambulation category
The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere).
Measured: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Fugl-meyer assessment
Measured: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Medical research council
The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed)
Measured: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Trunk control test
Measured: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMar 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hyun, Veterans Health Service Medical Center, Seoul, Korea
- Investigators
- Dae Hyun Kim, Master, Principal investigator, Veterans hospital, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569190
- Sponsor's protocol ID
- 2015-05-008-002
- Status last verified
- Apr 2016
- First submitted
- 18 Sep 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT02569190
- Acronym / sponsor ID
- 2015-05-008-002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, KoreaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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.
Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.
Detailed description
This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walkbot | Experimental | Device: WalkbotReceive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke attack
- Within 3 months after stroke onset
- Supratentorial stroke
- Unilateral stroke
Key exclusion criteria (4 listed)
- Bilateral stroke
- infratentorial stroke
- Cognitive disabilities or serious psychiatric illness.
- Difficulty in walking due to orthopedic problems.
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 |
|---|---|---|
| WalkbotRobot assisted gait training | Device | Walkbot |
Primary outcome
Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention
Time frame: at the first day of intervention and 8 weeks after the first day
4 secondary outcomes
Functional ambulation category
Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Fugl-meyer assessment
Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Medical research council
Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Trunk control test
Time frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
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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.
Dae Hyun Kim, Master principal investigator
Veterans hospital, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walkbot in people with Stroke, run by Veterans Health Service Medical 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 4 inclusion and 4 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 2016. 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 from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention (time frame: at the first day of intervention and 8 weeks after the first day). 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 29 Apr 2016.