Acute Hemiplegic Stroke Including Subacute PhasesNCT04649684
The Effectiveness of Exoskeleton Type Robotic Gait Training Using CIMT for Lower Extremity: in the Aspect of Gait Independence and Balance
A study testing Conventional robot-assisted gait training and Lower CIMT robot-assisted gait training group in people with Acute Hemiplegic Stroke Including Subacute Phases, run by Yonsei University at 1 site in South Korea.
Trial summary
The prevalence of stroke has reached 795,000 a year worldwide, which cannot be overlooked. In stroke patients, gait disorder is the most common among the complications of stroke, which is known to have the greatest adverse effect. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Hemiplegic Stroke Including Subacute Phases
- What is being tested?
- Conventional robot-assisted gait training and Lower CIMT robot-assisted gait training group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Mar 2019to 30 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients admitted at the Department of Rehabilitation.
- Age over 19 years old
- Diagnosed by brain magnetic resonance imaging or computed brain tomography
- Acute and subacute patients with less than 3 months of stroke onset
- Those who show hemiplegia after stroke
- Those who are able to execute orders of one or more steps
Show all 9Show fewer
- A person who cannot walk independently with 2 points or less in the Functional Ambulation Category (FAC)
- Those whose Dynamic/Static sitting balance is measured above Fair grade
- Patients who understand the study, are willing to participate, and agree to participate
Who cannot join
- Persons with impaired walking before stroke
- Those who shows spasticity measured by Modified Ashwoth scale of 3 or more
- Patients with ataxia
- Contraindications to weight-bearing of the lower extremities such as severe joint construction, osteoporosis, and untreated fractures
- Patients weighing over 135kg
- Damage to the skin in contact with the machine when walking with robot assisted device
Show all 14Show fewer
- Patients who underwent orthopedic or neurosurgery surgery within 6 months of the start of the study
- Uncontrolled high blood pressure or orthostatic hypotension clinically
- Patients with potential for transmission of pathogenic microorganisms through contact
- Lower limb amputated status
- Cardiovascular disease, venous thrombosis or heart failure, respiratory disease that may affect heart function during exercise load
- Those who was diagnosed malignant neoplasm
- Other underlying diseases that cannot withstand robot-assisted walking
- Patients judged to be unsuitable for this study by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Deog Young Kim, +82-10-3766-1867, KIMDY@yuhs.ac
About this study
The prevalence of stroke has reached 795,000 a year worldwide, which cannot be overlooked. In stroke patients, gait disorder is the most common among the complications of stroke, which is known to have the greatest adverse effect. One of the important goals of rehabilitation after a stroke is the restoration of symmetry and balance of locomotion to prevent complications such as fall.
Meanwhile, various methods have been devised in addition to the conventional physical therapy using physical efforts of a physical therapist as a rehabilitation treatment designed to improve gait exercise capacity including body weight-supported treadmill training, Hydrotherapy and robot-assisted gait training.
Read more
Especially in the case of robot-assisted gait training, it is proven to be more effective in terms of gait function recovery compared to the patient group who only undergoes conventional physical therapy.
Robot-assisted gait training can be divided into two types according to the driven principle, exoskeleton-type robot assisted gait training and end-effector gait training. Among them, exoskeleton-type robotic gait training has distinctive feature from another type, the guidance force, which assists the movement of the lower extremities throughout the entire gait cycle according to a pre-set joint trajectory data based on healthy people. For patients who are currently unable to walk, task-oriented sensory information can be provided using this concept diversifying the degree of guidance force for affected lower limb as well as unaffected lower limb.
Many studies have set the degree of guidance force to 100% at the side of affected limb at first and then gradually reduce the degree of guidance force to the extent that the patient is tolerable. In contrast, in the case of unaffected limb, there is no mention of the degree of guidance force setting.
But, the most representative characteristic of walking is bipedal. Considering the fact that recovering the gait symmetry is the biggest challenge for stroke patients, there is a limitation when not taking into account the activity of the unaffected side.
In this respect, this study investigates the effectiveness of constraint-induced movement therapy (CIMT) for lower extremity by modulating degree of guidance force during exoskeleton-type robotic-assisted gait training
In this study, a group of patients with acute hemiplegic stroke including subacute phases, less than 3 months after onset were included. And all experiments were conducted over 4 weeks. The group was divided into three: the first group got conventional robot-assisted gait training, guidance force given equally to both limbs. Second group received only conventional gait therapy conducted by physical therapists without robotic gait therapy for the same period of time. The third group got robot-assisted gait training based on CIMT concept;
100% guidance force is given on the unaffected side and then verbal ques are given not to contract unaffected muscle voluntarily as much as possible are provided by physical therapists, automatically according to the predetermined joint trajectory. In contrast at the affected side, gradually reduce the degree of guidance force to the extent that the patient is tolerable.
The purpose of this study is to analyze the clinical gait index afterwards to find out whether the group that performed robot gait training using healthy leg restriction therapy is more effective in improving gait pattern and gait independence than the rest of the group.
The purpose of this study was to compare the clinical gait index before, after completion of therapy, and 4 weeks after completion of therapy among three group and prove the effectiveness of robot-assisted gait training based on CIMT concept in the aspect of gait patterns and gait independence index.
- Being tested
- Conventional robot-assisted gait training, Lower CIMT robot-assisted gait training group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional robot-assisted gait trainingDevice
They got conventional robot-assisted gait training, guidance force given equally to both limbs, and then gradually reduce the degree of guidance force to the extent that the patient is tolerable equally .during 4- week treatment session
Lower CIMT robot-assisted gait training groupDevice
They got robot-assisted gait training based on CIMT concept; 100% guidance force is given on the unaffected side and then verbal ques are given not to contract unaffected muscle voluntarily as much as possible are provided, automatically according to the predetermined joint trajectory. In contrast at the affected side, gradually reduce the degree of guidance force to the extent that the patient is tolerable.
| Study group | Role | What they receive |
|---|---|---|
| Conventional robot-assisted gait training group | Experimental | they got conventional robot-assisted gait training, guidance force given equally to both limbs Receives: Device: Conventional robot-assisted gait training |
| Lower CIMT robot-assisted gait training group | Experimental | they got robot-assisted gait training based on CIMT concept Receives: Device: Lower CIMT robot-assisted gait training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ambulatory category
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points
- A score of 0 indicates that the patient is a non-functional ambulator (cannot walk);
- A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3)
- A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Measured: Before the study
Functional ambulatory category
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points
- A score of 0 indicates that the patient is a non-functional ambulator (cannot walk);
- A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3)
- A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Measured: After the study(4 weeks after start)
Functional ambulatory category
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points
- A score of 0 indicates that the patient is a non-functional ambulator (cannot walk);
- A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3)
- A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Measured: 4 weeks after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start13 Mar 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hemiplegic Stroke Including Subacute PhasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649684
- Sponsor's protocol ID
- 1-2019-0002
- Status last verified
- May 2021
- First submitted
- 25 Nov 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exoskeleton Type Robotic Gait Training Using CIMT for Lower Extremity: in the Aspect of Gait Independence and Balance
- ClinicalTrials.gov ID
- NCT04649684
- Acronym / sponsor ID
- 1-2019-0002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 2 Dec 2020 (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.
The prevalence of stroke has reached 795,000 a year worldwide, which cannot be overlooked. In stroke patients, gait disorder is the most common among the complications of stroke, which is known to have the greatest adverse effect. One of the important goals of rehabilitation after a stroke is the restoration of symmetry and balance of locomotion to prevent complications such as fall.
Meanwhile, various methods have been devised in addition to the conventional physical therapy using physical efforts of a physical therapist as a rehabilitation treatment designed to improve gait exercise capacity including body weight-supported treadmill training, Hydrotherapy and robot-assisted gait training.
Especially in the case of robot-assisted gait training, it is proven to be more effective in terms of gait function recovery compared to the patient group who only undergoes conventional physical therapy.
Robot-assisted gait training can be divided into two types according to the driven principle, exoskeleton-type robot assisted gait training and end-effector gait training. Among them, exoskeleton-type robotic gait training has distinctive feature from another type, the guidance force, which assists the movement of the lower extremities throughout the entire gait cycle according to a pre-set joint trajectory data based on healthy people. For patients who are currently unable to walk, task-oriented sensory information can be provided using this concept diversifying the degree of guidance force for affected lower limb as well as unaffected lower limb.
Many studies have set the degree of guidance force to 100% at the side of affected limb at first and then gradually reduce the degree of guidance force to the extent that the patient is tolerable. In contrast, in the case of unaffected limb, there is no mention of the degree of guidance force setting.
But, the most representative characteristic of walking is bipedal. Considering the fact that recovering the gait symmetry is the biggest challenge for stroke patients, there is a limitation when not taking into account the activity of the unaffected side.
In this respect, this study investigates the effectiveness of constraint-induced movement therapy (CIMT) for lower extremity by modulating degree of guidance force during exoskeleton-type robotic-assisted gait training
In this study, a group of patients with acute hemiplegic stroke including subacute phases, less than 3 months after onset were included. And all experiments were conducted over 4 weeks. The group was divided into three: the first group got conventional robot-assisted gait training, guidance force given equally to both limbs. Second group received only conventional gait therapy conducted by physical therapists without robotic gait therapy for the same period of time. The third group got robot-assisted gait training based on CIMT concept;
100% guidance force is given on the unaffected side and then verbal ques are given not to contract unaffected muscle voluntarily as much as possible are provided by physical therapists, automatically according to the predetermined joint trajectory. In contrast at the affected side, gradually reduce the degree of guidance force to the extent that the patient is tolerable.
The purpose of this study is to analyze the clinical gait index afterwards to find out whether the group that performed robot gait training using healthy leg restriction therapy is more effective in improving gait pattern and gait independence than the rest of the group.
The purpose of this study was to compare the clinical gait index before, after completion of therapy, and 4 weeks after completion of therapy among three group and prove the effectiveness of robot-assisted gait training based on CIMT concept in the aspect of gait patterns and gait independence index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional robot-assisted gait training group | Experimental | Device: Conventional robot-assisted gait trainingthey got conventional robot-assisted gait training, guidance force given equally to both limbs |
| Lower CIMT robot-assisted gait training group | Experimental | Device: Lower CIMT robot-assisted gait training groupthey got robot-assisted gait training based on CIMT concept |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stroke patients admitted at the Department of Rehabilitation.
- Age over 19 years old
- Diagnosed by brain magnetic resonance imaging or computed brain tomography
- Acute and subacute patients with less than 3 months of stroke onset
- Those who show hemiplegia after stroke
Key exclusion criteria (14 listed)
- Persons with impaired walking before stroke
- Those who shows spasticity measured by Modified Ashwoth scale of 3 or more
- Patients with ataxia
- Contraindications to weight-bearing of the lower extremities such as severe joint construction, osteoporosis, and untreated fractures
- Patients weighing over 135kg
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 |
|---|---|---|
| Conventional robot-assisted gait trainingThey got conventional robot-assisted gait training, guidance force given equally to both limbs, and then gradually reduce the degree of guidance force to the extent that the patient is tolerable equally .during 4- week treatment session | Device | Conventional robot-assisted gait training group |
| Lower CIMT robot-assisted gait training groupThey got robot-assisted gait training based on CIMT concept; 100% guidance force is given on the unaffected side and then verbal ques are given not to contract unaffected muscle voluntarily as much as possible are provided, automatically according to the predetermined joint trajectory. In contrast at the affected side, gradually reduce the degree of guidance force to the extent that the patient is tolerable. | Device | Lower CIMT robot-assisted gait training group |
Primary outcome
Functional ambulatory category
Time frame: Before the study
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points * A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); * A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) * A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Functional ambulatory category
Time frame: After the study(4 weeks after start)
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points * A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); * A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) * A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Functional ambulatory category
Time frame: 4 weeks after study
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. It ranges from 0 to 5 points * A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); * A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) * A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score) (Holden et al., 1984)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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.
Deog Young Kim principal investigator
Severance 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 Conventional robot-assisted gait training and Lower CIMT robot-assisted gait training group in people with Acute Hemiplegic Stroke Including Subacute Phases, run by Yonsei University 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 9 inclusion and 14 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 21 May 2021. 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 Deog Young Kim (+82-10-3766-1867, kimdy@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ambulatory category (time frame: Before the study). The study lists 3 primary outcomes in all. 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 21 May 2021.