StrokeWalkbotNCT02694302
Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
A study testing Walkbot and Conventional physical therapy in people with Stroke, run by P&S Mechanics Co., Ltd. at 2 sites in South Korea.
Trial summary
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Walkbot and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2014to Jul 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 19 and under 80
- Weight under 100kg
- Height less than 200cm
- Able to walk independently before onset of stroke
- Ischemic or hemorrhagic stroke patients
- Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
Show all 10Show fewer
- FAC(Functional Ambulation Category) under 3 (0~2)
- Subacute stroke patients after 3 days and before 3 months of onset
- Be informed of the nature of the study and agreed on written consent voluntarily
- Patients taking medications or scheduled medications due to stroke
Who cannot join
- Patients with contraindications to weight bearing such as fractures, etc.
- Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
- Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
- Patients with severe skin damage and bedsore on wearing part of the trial device
- Pregnant or breast-feeding
- Participation within 30 days of the other clinical trials
- Patients whom the investigator considers inappropriate to participate in the study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Rehabilitation Center
Seoul, 01022
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Read the detailed description
Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Experimental group receives robot-assisted-gait-training and conventional gait training.
Active comparator group receives conventional gait training only as the same number as the experimental group.
- Conditions
- Stroke
- Being tested
- Walkbot, Conventional physical therapy
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkbotDevice
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
Conventional physical therapyDevice
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Walkbot | Experimental | Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks. Receives: Device: Walkbot; Device: Conventional physical therapy |
| Conventional physical therapy | Active comparator | Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks. Receives: Device: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Category(FAC)
Measured: 9 weeks from baseline
Secondary outcomes (10)
Motricity Index(MI)
Measured: 9 weeks from baseline
10 Meter Walk Test(10MWT)
Measured: 9 weeks from baseline
6 Minute Walk Test(6MWT)
Measured: 9 weeks from baseline
Medical Research Council(MRC) Scale
Measured: 9 weeks from baseline
Modified Ashworth Scale (MAS)
Measured: 9 weeks from baseline
Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke
Measured: 9 weeks from baseline
Modified Barthel Index(MBI)
Measured: 9 weeks from baseline
National Institutes of Health Stroke Scale (NIHSS)
Measured: 9 weeks from baseline
Beck's Depression Inventory test (BDI)
Measured: 9 weeks from baseline
Treatment Satisfaction Survey
Measured: 9 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 posted29 Feb 2016 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- P&S Mechanics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Hwan Kim, MD, PhD, Principal investigator, National Rehabilitation Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694302
- Sponsor's protocol ID
- UMT2013-PS-WB-01
- Acronym
- Walkbot
- Status last verified
- Sep 2016
- First submitted
- 18 Feb 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training
- ClinicalTrials.gov ID
- NCT02694302
- Acronym / sponsor ID
- Walkbot / UMT2013-PS-WB-01
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- P&S Mechanics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Feb 2016 (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.
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Detailed description
Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Experimental group receives robot-assisted-gait-training and conventional gait training.
Active comparator group receives conventional gait training only as the same number as the experimental group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walkbot | Experimental | Device: Walkbot, Device: Conventional physical therapyWalkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks. |
| Conventional physical therapy | Active comparator | Device: Conventional physical therapyConventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age more than 19 and under 80
- Weight under 100kg
- Height less than 200cm
- Able to walk independently before onset of stroke
- Ischemic or hemorrhagic stroke patients
Key exclusion criteria (7 listed)
- Patients with contraindications to weight bearing such as fractures, etc.
- Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
- Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
- Patients with severe skin damage and bedsore on wearing part of the trial device
- Pregnant or breast-feeding
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 |
|---|---|---|
| WalkbotWalkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks. | Device | Walkbot |
| Conventional physical therapyConventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks. | Device | Conventional physical therapy, Walkbot |
Primary outcome
Functional Ambulation Category(FAC)
Time frame: 9 weeks from baseline
10 secondary outcomes
Motricity Index(MI)
Time frame: 9 weeks from baseline
10 Meter Walk Test(10MWT)
Time frame: 9 weeks from baseline
6 Minute Walk Test(6MWT)
Time frame: 9 weeks from baseline
Medical Research Council(MRC) Scale
Time frame: 9 weeks from baseline
Modified Ashworth Scale (MAS)
Time frame: 9 weeks from baseline
Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke
Time frame: 9 weeks from baseline
Modified Barthel Index(MBI)
Time frame: 9 weeks from baseline
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 9 weeks from baseline
Beck's Depression Inventory test (BDI)
Time frame: 9 weeks from baseline
Treatment Satisfaction Survey
Time frame: 9 weeks from baseline
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 27 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Jung Hwan Kim, MD, PhD principal investigator
National Rehabilitation Center, Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walkbot and Conventional physical therapy in people with Stroke, run by P&S Mechanics Co., Ltd. at 2 sites 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 7 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional Ambulation Category(FAC) (time frame: 9 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 27 Sep 2016.