Cerebral PalsyNCT04909151
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
A study testing Robot-assisted gait training (walking speed: 0.5km/h), Robot-assisted gait training (walking speed: 0.8km/h) and Robot-assisted gait training (walking speed: 1.1km/h) in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Sahmyook University at 1 site in South Korea.
Trial summary
Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic, Bilateral Spastic Cerebral Palsy
- What is being tested?
- Robot-assisted gait training (walking speed: 0.5km/h), Robot-assisted gait training (walking speed: 0.8km/h) and Robot-assisted gait training (walking speed: 1.1km/h)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2021to 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 4-12 years old diagnosed with cerebral palsy
- Children who have not received botulinum toxin treatment or surgery within 3 months
- Children in stage 2 of the gross motor function system
- Children who can express pain, fear, or discomfort on their own
Who cannot join
- Severe lower extremity contracture and fracture
- Bone instability
- Osteoporosis
- Severe bones grow disproportionately
- Unhealed skin lesions on the lower extremities (thromboembolic disease)
- Thromboembolic disease
- Cardiovascular instability
- Mild scoliosis with a Cobb's angle of more than 20 degrees
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pajucity convalescent Hospital
Paju, 10915
Sun-Geon Park, +82-31-942-7500, spring1056@naver.com
About this study
Official title: The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy
Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.
- Being tested
- Robot-assisted gait training (walking speed: 0.5km/h), Robot-assisted gait training (walking speed: 0.8km/h), Robot-assisted gait training (walking speed: 1.1km/h)
- 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 training (walking speed: 0.5km/h)Device
Robot-assisted gait training 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.
Robot-assisted gait training (walking speed: 0.8km/h)Device
Robot-assisted gait training 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.
Robot-assisted gait training (walking speed: 1.1km/h)Device
Robot-assisted gait training 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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted gait training with walking speed of 0.5km/h | Experimental | Not described Receives: Device: Robot-assisted gait training (walking speed: 0.5km/h) |
| Robot-assisted gait training with walking speed of 0.8km/h | Experimental | Not described Receives: Device: Robot-assisted gait training (walking speed: 0.8km/h) |
| Robot-assisted gait training with walking speed of 1.1km/h | Experimental | Not described Receives: Device: Robot-assisted gait training (walking speed: 1.1km/h) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait ability
Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.
Measured: Change from baseline gait ability at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start18 Jun 2021
- Primary completion30 Sep 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 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
- Investigators
- Sun-Geon Park, Ph.D candidate, Principal investigator, The Wells Neuro Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909151
- Sponsor's protocol ID
- 2-1040781-A-N-012021050HR
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 21 Jun 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04909151
- Acronym / sponsor ID
- 2-1040781-A-N-012021050HR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 1 Jun 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.
Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted gait training with walking speed of 0.5km/h | Experimental | Device: Robot-assisted gait training (walking speed: 0.5km/h) |
| Robot-assisted gait training with walking speed of 0.8km/h | Experimental | Device: Robot-assisted gait training (walking speed: 0.8km/h) |
| Robot-assisted gait training with walking speed of 1.1km/h | Experimental | Device: Robot-assisted gait training (walking speed: 1.1km/h) |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients 4-12 years old diagnosed with cerebral palsy
- Children who have not received botulinum toxin treatment or surgery within 3 months
- Children in stage 2 of the gross motor function system
- Children who can express pain, fear, or discomfort on their own
Key exclusion criteria (8 listed)
- Severe lower extremity contracture and fracture
- Bone instability
- Osteoporosis
- Severe bones grow disproportionately
- Unhealed skin lesions on the lower extremities (thromboembolic disease)
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 training (walking speed: 0.5km/h)Robot-assisted gait training 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. | Device | Robot-assisted gait training with walking speed of 0.5km/h |
| Robot-assisted gait training (walking speed: 0.8km/h)Robot-assisted gait training 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. | Device | Robot-assisted gait training with walking speed of 0.8km/h |
| Robot-assisted gait training (walking speed: 1.1km/h)Robot-assisted gait training 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. | Device | Robot-assisted gait training with walking speed of 1.1km/h |
Primary outcome
Gait ability
Time frame: Change from baseline gait ability at 6 weeks
Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided. I plan to decide after the study is over.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Sun-Geon Park, Ph.D candidate principal investigator
The Wells Neuro Pain Clinic
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 (walking speed: 0.5km/h), Robot-assisted gait training (walking speed: 0.8km/h) and Robot-assisted gait training (walking speed: 1.1km/h) in people with Cerebral Palsy and Gait Disorders, Neurologic, 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 8 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 Jun 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 Sun-Geon Park, Ph.D candidate (+82-10-6204-8377, spring1056@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait ability (time frame: Change from baseline gait ability at 6 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 21 Jun 2021.