StrokeNCT02755415
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
A study testing HIWIN Robotic Gait Training System and Static Standing Table in people with Stroke, 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 acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- HIWIN Robotic Gait Training System and Static Standing Table
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the age of 20-80 years;
- Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
- Paresis of a lower limb;
- Ability to walk for only a few meters either with or without aid.
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 Hospital
Taichung, 408
Li-Wei Chou, MD, MSc, +886-4-22052121 ext. 2381, chouliwe@gmail.com
Li-Wei Chou, MD, PhD, MSc
About this study
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.
Read the detailed description
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.
- Conditions
- Stroke
- Being tested
- HIWIN Robotic Gait Training System, Static Standing Table
- Keywords
- Rehabilitation, Robotic, Gait, Quality of Life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIWIN Robotic Gait Training SystemDevice
HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
Static Standing TableOther
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
| Study group | Role | What they receive |
|---|---|---|
| Static Standing Table Training | Active comparator | Patients in this group will receive standard hospital based rehabilitation as well as static standing table training Receives: Other: Static Standing Table |
| Robotic Gait Training | Experimental | Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training Receives: Device: HIWIN Robotic Gait Training System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
Measured: 15-20 minutes
Secondary outcomes (6)
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
Measured: 10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
Measured: 10-15 minutes
Resting muscle tone
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Measured: 10 minutes
Resting muscle elasticity
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Measured: 10 minutes
Six minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: 6 minutes
Beck's depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: 7-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionApr 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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755415
- Sponsor's protocol ID
- CMUH105-REC1-037
- Status last verified
- Jul 2016
- First submitted
- 21 Apr 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will remain confidential and accessible to only the approved researchers
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 Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT02755415
- Acronym / sponsor ID
- CMUH105-REC1-037
- Conditions
- Stroke
- Keywords
- Rehabilitation, Robotic, Gait, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Apr 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 acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.
Detailed description
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static Standing Table Training | Active comparator | Other: Static Standing TablePatients in this group will receive standard hospital based rehabilitation as well as static standing table training |
| Robotic Gait Training | Experimental | Device: HIWIN Robotic Gait Training SystemPatients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the age of 20-80 years;
- Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
- Paresis of a lower limb;
- Ability to walk for only a few meters either with or without aid.
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 |
|---|---|---|
| HIWIN Robotic Gait Training SystemHIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training | Device | Robotic Gait Training |
| Static Standing TableAs part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position | Other | Static Standing Table Training |
Primary outcome
Berg Balance Scale
Time frame: 15-20 minutes
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
6 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: 10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: 10-15 minutes
Resting muscle tone
Time frame: 10 minutes
Resting muscle elasticity
Time frame: 10 minutes
Six minute walk test
Time frame: 6 minutes
Beck's depression Inventory
Time frame: 7-10 minutes
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: No. Individual participant data will remain confidential and accessible to only the approved researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIWIN Robotic Gait Training System and Static Standing Table in people with Stroke, 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 15-20 minutes). 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.