Cerebral PalsyNCT04884386
Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
A study testing robot-assisted gait training and conventional locomotion therapy in people with Cerebral Palsy and Spastic Hemiplegic Cerebral Palsy, run by Sahmyook University at 1 site in South Korea.
Trial summary
In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Bilateral Spastic Cerebral Palsy
- What is being tested?
- robot-assisted gait training and conventional locomotion therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2021to 30 Sep 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
- Patients diagnosed with Bilateral Spastic Cerebral Palsy
- Patients diagnosed with Spastic Hemiplegic Cerebral Palsy
Who cannot join
- Children who cannot understand and follow orders
- Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
- Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
- Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial
In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.
- Conditions
- Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Bilateral Spastic Cerebral Palsy, Gait Disorders, Neurologic
- Being tested
- robot-assisted gait training, conventional locomotion therapy
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted gait trainingDevice
RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
conventional locomotion therapyBehavioural
locomotion exercise, postural control training, balance training, electrotherapy
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted gait training | Experimental | Not described Receives: Device: robot-assisted gait training; Behavioral: conventional locomotion therapy |
| conventional locomotion therapy | Active comparator | Not described Receives: Behavioral: conventional locomotion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle activation
Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do
Measured: Change from baseline muscle activation 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 posted13 May 2021
- Study start12 Jun 2021
- Primary completion30 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884386
- Sponsor's protocol ID
- 2-1040781-A-N-012021048HR
- Status last verified
- Nov 2021
- First submitted
- 8 May 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I plan to decide after the study is over.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04884386
- Acronym / sponsor ID
- 2-1040781-A-N-012021048HR
- Conditions
- Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Bilateral Spastic Cerebral Palsy, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 May 2021 (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.
In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted gait training | Experimental | Device: robot-assisted gait training, Behavioral: conventional locomotion therapy |
| conventional locomotion therapy | Active comparator | Behavioral: conventional locomotion therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
- Patients diagnosed with Bilateral Spastic Cerebral Palsy
- Patients diagnosed with Spastic Hemiplegic Cerebral Palsy
Key exclusion criteria (4 listed)
- Children who cannot understand and follow orders
- Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
- Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
- Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more
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 |
|---|---|---|
| robot-assisted gait trainingRAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint. | Device | robot-assisted gait training |
| conventional locomotion therapylocomotion exercise, postural control training, balance training, electrotherapy | Behavioural | conventional locomotion therapy, robot-assisted gait training |
Primary outcome
muscle activation
Time frame: Change from baseline muscle activation at 4 weeks
Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do
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 22 Nov 2021.
- Individual participant dataSharing planned: Undecided. I plan to decide after the study is over.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted gait training and conventional locomotion therapy in people with Cerebral Palsy and Spastic Hemiplegic Cerebral Palsy, 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 3 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: finished, as of the sponsor's last update on 22 Nov 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?
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?
muscle activation (time frame: Change from baseline muscle activation at 4 weeks). 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 22 Nov 2021.