StrokeNCT06476327
Robot-Assisted Gait Training With Self-Observation in Stroke Rehabilitation
A study testing experimental 1 group and experimental 2 group in people with Stroke, run by Sahmyook University at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- experimental 1 group and experimental 2 group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2024to Oct 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have had a stroke for more than 6 months but less than 1 year
- Functional Ambulation Category (FAC) ≥ 2
- Able to walk 10 meters independently with or without an assistive device
- Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)
Who cannot join
- Inability to wear the robot due to open wounds or skin conditions
- Severe cognitive impairment (MMSE-K < 10) or significant difficulty in communication due to language disorders
- Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
- High risk of fractures, such as osteoporosis
- Severe cardiovascular or pulmonary diseases
- Neurological disorders affecting gait function, such as Parkinson's disease or multiple sclerosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungdam hospital
Seoul, Gangnam-gu, 06063
Hyeri Lee, +82-10-6377-9341, hee03088@naver.com
About this study
Official title: The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke
The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:
Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?
Participants will be
Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.
Group 2 Perform robot-assisted gait training five times a week for four weeks.
All groups perform for 30 minutes per session.
- Conditions
- Stroke
- Being tested
- experimental 1 group, experimental 2 group
- Keywords
- stroke, gait, cognitive function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental 1 groupBehavioural
A camera is installed on the walker used in the training, and the recorded video is mirrored in real-time to a tablet computer. Participants can view this video through smart glasses connected to the tablet computer. A glasses strap will be used to secure the glasses, ensuring there is no interference with walking.
Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session.
Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.
experimental 2 groupBehavioural
Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session.
Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.
| Study group | Role | What they receive |
|---|---|---|
| experimental 1 group | Active comparator | Robot-Assisted Gait with Self-Observation Receives: Behavioral: experimental 1 group |
| experimental 2 group | Active comparator | Robot-Assisted Gait Receives: Behavioral: experimental 2 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance ability
- Timed up and go test (TUG)
Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance.
- Functional Reach Test (FRT)
Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone.
Measured: from enrollment to the end of treatment at 4 weeks
Gait ability
-10 meter walking test (10MWT)
The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.).
-GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA)
Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables.
Measured: from enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Cognitive ability
- Mini-Mental Status Examination-Korea, (MMSE-K)
Consists of memory, recall ability, attention, language skills, numerical ability, and constructional ability.
Memory has 10 points, registration has 3 points, attention and calculation have 5 points, recall has 3 points, language function has 7 points, and comprehension and judgment have 2 points, totaling six areas and twelve items
Measured: from enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (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.
- 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476327
- Sponsor's protocol ID
- SYU 2024-05-017
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke
- ClinicalTrials.gov ID
- NCT06476327
- Acronym / sponsor ID
- SYU 2024-05-017
- Conditions
- Stroke
- Keywords
- stroke, gait, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Jun 2024 (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 aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:
Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?
Participants will be
Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.
Group 2 Perform robot-assisted gait training five times a week for four weeks.
All groups perform for 30 minutes per session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental 1 group | Active comparator | Behavioral: experimental 1 groupRobot-Assisted Gait with Self-Observation |
| experimental 2 group | Active comparator | Behavioral: experimental 2 groupRobot-Assisted Gait |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who have had a stroke for more than 6 months but less than 1 year
- Functional Ambulation Category (FAC) ≥ 2
- Able to walk 10 meters independently with or without an assistive device
- Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)
Key exclusion criteria (6 listed)
- Inability to wear the robot due to open wounds or skin conditions
- Severe cognitive impairment (MMSE-K < 10) or significant difficulty in communication due to language disorders
- Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
- High risk of fractures, such as osteoporosis
- Severe cardiovascular or pulmonary diseases
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 |
|---|---|---|
| experimental 1 groupA camera is installed on the walker used in the training, and the recorded video is mirrored in real-time to a tablet computer. Participants can view this video through smart glasses connected to the tablet computer. A glasses strap will be used to secure the glasses, ensuring there is no interference with walking. Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session. Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation. | Behavioural | experimental 1 group |
| experimental 2 groupParticipants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session. Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation. | Behavioural | experimental 2 group |
Primary outcome
Balance ability
Time frame: from enrollment to the end of treatment at 4 weeks
- Timed up and go test (TUG) Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance. - Functional Reach Test (FRT) Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone.
Gait ability
Time frame: from enrollment to the end of treatment at 4 weeks
-10 meter walking test (10MWT) The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.). -GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA) Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables.
1 secondary outcome
Cognitive ability
Time frame: from enrollment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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 experimental 1 group and experimental 2 group in people with Stroke, run by Sahmyook 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 4 inclusion and 6 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 1 Jul 2024. 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 Hyeri Lee (+82-10-6377-9341, hee03088@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance ability (time frame: from enrollment to the end of treatment at 4 weeks). The study lists 2 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 1 Jul 2024.