Cerebrovascular AccidentNCT02781831
Robot-assisted Gait Training for Patients With Stroke
A study testing Standard rehab and Robot-assisted gait rehabilitation in people with Cerebrovascular Accident, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Standard rehab and Robot-assisted gait rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the age of 20-65 years;
- Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
- Paresis of a lower limb;
- Inability to walk without aid or device.
Who cannot join
- Deemed by a physician to be medically unstable;
- Other prior musculoskeletal conditions that affected gait capacity;
- Co-existence of other neurological diseases;
- Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospial
Taichung, Taiwan, 404
Nai-Hsin Meng, M.D., 886-4-22052121 ext. 2381, nsmeng@ms13.hinet.net
Nai-Hsin Meng, M.D.
About this study
Official title: Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.
Read the detailed description
Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.
- Conditions
- Cerebrovascular Accident
- Being tested
- Standard rehab, Robot-assisted 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.
Standard rehabProcedure or surgery
Standard hospital based rehabilitation for patients with stroke
Robot-assisted gait rehabilitationDevice
An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation | Active comparator | Patient with stroke receiving standard hospital based rehabilitation program Receives: Procedure: Standard rehab |
| Robot-assisted Rehabilitation | Experimental | Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program Receives: Device: Robot-assisted gait rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment, lower extremity subscale
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
Measured: Assessing change from baseline after 1 month of intervention
Secondary outcomes (5)
Functional Ambulation Categories
Categorizes patients according to basic motor skills necessary for functional ambulation
Measured: Assessing change from baseline after 1 month of intervention
10 Meters Walking Test
Assesses walking speed in meters per second over a short duration
Measured: Assessing change from baseline after 1 month of intervention
Berg Balance Scale
testing a participant's static and dynamic balance abilities
Measured: Assessing change from baseline after 1 month of intervention
Timed Up and Go test
Assess a participant's mobility and requires both static and dynamic balance
Measured: Assessing change from baseline after 1 month of intervention
Kinetic and Kinematic Gait Analysis
The temporo-spatial and kinematic gait parameters of the participants will be assessed using a Vicon Motion Analysis System with kinetic data collection through a force plate.
Measured: Assessing change from baseline after 1 month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HIWIN Technologies Corporation
- Responsible party
- Sponsor
- Investigators
- Nai-Hsin Meng, M.D., Principal investigator, China Medical University, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781831
- Sponsor's protocol ID
- HIWIN-CMU-C-105-1
- Status last verified
- Jul 2016
- First submitted
- 3 May 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
- ClinicalTrials.gov ID
- NCT02781831
- Acronym / sponsor ID
- HIWIN-CMU-C-105-1
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- HIWIN Technologies Corporation
- Study start
- May 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 May 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.
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.
Detailed description
Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation | Active comparator | Procedure: Standard rehabPatient with stroke receiving standard hospital based rehabilitation program |
| Robot-assisted Rehabilitation | Experimental | Device: Robot-assisted gait rehabilitationPatient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the age of 20-65 years;
- Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
- Paresis of a lower limb;
- Inability to walk without aid or device.
Key exclusion criteria (4 listed)
- Deemed by a physician to be medically unstable;
- Other prior musculoskeletal conditions that affected gait capacity;
- Co-existence of other neurological diseases;
- Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -
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 |
|---|---|---|
| Standard rehabStandard hospital based rehabilitation for patients with stroke | Procedure or surgery | Standard Rehabilitation |
| Robot-assisted gait rehabilitationAn extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke | Device | Robot-assisted Rehabilitation |
Primary outcome
Fugl-Meyer Assessment, lower extremity subscale
Time frame: Assessing change from baseline after 1 month of intervention
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
5 secondary outcomes
Functional Ambulation Categories
Time frame: Assessing change from baseline after 1 month of intervention
10 Meters Walking Test
Time frame: Assessing change from baseline after 1 month of intervention
Berg Balance Scale
Time frame: Assessing change from baseline after 1 month of intervention
Timed Up and Go test
Time frame: Assessing change from baseline after 1 month of intervention
Kinetic and Kinematic Gait Analysis
Time frame: Assessing change from baseline after 1 month of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Nai-Hsin Meng, M.D. principal investigator
China Medical University, China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehab and Robot-assisted gait rehabilitation in people with Cerebrovascular Accident, run by China Medical University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 27 Jul 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 Taiwan. 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 Nai-Hsin Meng, M.D. (886-4-22052121 ext. 2381, nsmeng@ms13.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment, lower extremity subscale (time frame: Assessing change from baseline after 1 month of intervention). 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 Jul 2016.