Cerebral Palsy, SpasticNCT05388422
Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy
A study testing Application of 3D scanner to measure physical size in patients with severe cerebral palsy in people with Cerebral Palsy, Spastic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Application of 3D scanner to measure physical size in patients with severe cerebral palsy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2022to 31 Mar 2023
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of cerebral palsy
- age 1-15 years
- GMFCS Level IV, V
- quadriplegia, or diplegia for more than 6 months
- Patients who have written consent with permission from the child and caregiver.
Who cannot join
- Patients who did not agree to participate in the study
- Patients who refused the examination
- Patients who had hip surgery experience
- Patients who were scheduled to undergo surgery during the clinical study
- Patients who could not be measured with a 3D scanner
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices
The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.
Read the detailed description
- Design : Prospective Study
- Setting: Hospital rehabilitation department and Home
- Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
- Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Application of 3D scanner to measure physical size in patients with severe cerebral palsy
- Keywords
- 3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of 3D scanner to measure physical size in patients with severe cerebral palsyDevice
Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
| Study group | Role | What they receive |
|---|---|---|
| Severe cerebral palsy (GMFCS IV and V) | Experimental | This study included patients with severe cerebral palsy (GMFCS IV and V) Receives: Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration index
Hip AP radiography
Measured: 1 weeks
Secondary outcomes (5)
Visual analog scale (Pain index)
measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Measured: 1 weeks
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
Measured: 1 weeks
Likert scale (score)
measure the satisfaction, and discomfort about hip protection orthosis expressed by score from 1 to 5. The closer to 1, the higher the satisfaction or comfort.
Measured: 1 weeks
Range of motion of hip joint
Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value.
Measured: 1 weeks
wearability test
the Wearability Test consisted of four questions on wearing sensation, five questions about on fit, and four questions on motion suitability evaluation. Each item was scored on 5-point scale, with a total score of 65.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start2 Jun 2022
- Primary completion31 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
- Investigators
- Juseok Ryu, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388422
- Sponsor's protocol ID
- E-2201-732-001
- Status last verified
- Apr 2023
- First submitted
- 12 May 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim JM, Lim J, Choi SY, Rhim SH, Beom J, Ryu JS. Application of 3D scanner to measure physical size and improvement of hip brace manufacturing technology in severe cerebral palsy patients. Sci Rep. 2023 Nov 24;13(1):20691. doi: 10.1038/s41598-023-47665-w.
PubMed 38001232
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices
- ClinicalTrials.gov ID
- NCT05388422
- Acronym / sponsor ID
- E-2201-732-001
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- 3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 24 May 2022 (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 improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.
Detailed description
- Design : Prospective Study
- Setting: Hospital rehabilitation department and Home
- Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
- Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe cerebral palsy (GMFCS IV and V) | Experimental | Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsyThis study included patients with severe cerebral palsy (GMFCS IV and V) |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- diagnosis of cerebral palsy
- age 1-15 years
- GMFCS Level IV, V
- quadriplegia, or diplegia for more than 6 months
- Patients who have written consent with permission from the child and caregiver.
Key exclusion criteria (5 listed)
- Patients who did not agree to participate in the study
- Patients who refused the examination
- Patients who had hip surgery experience
- Patients who were scheduled to undergo surgery during the clinical study
- Patients who could not be measured with a 3D scanner
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 |
|---|---|---|
| Application of 3D scanner to measure physical size in patients with severe cerebral palsyBefore starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed. | Device | Severe cerebral palsy (GMFCS IV and V) |
Primary outcome
Migration index
Time frame: 1 weeks
Hip AP radiography
5 secondary outcomes
Visual analog scale (Pain index)
Time frame: 1 weeks
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
Time frame: 1 weeks
Likert scale (score)
Time frame: 1 weeks
Range of motion of hip joint
Time frame: 1 weeks
wearability test
Time frame: 1 weeks
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 1 May 2023.
- Derived from this study: PubMed 38001232Kim JM, Lim J, Choi SY, Rhim SH, Beom J, Ryu JS. Application of 3D scanner to measure physical size and improvement of hip brace manufacturing technology in severe cerebral palsy patients. Sci Rep. 2023 Nov 24;13(1):20691. doi: 10.1038/s41598-023-47665-w.
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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.
Juseok Ryu principal investigator
Seoul National University Bundang 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 Application of 3D scanner to measure physical size in patients with severe cerebral palsy in people with Cerebral Palsy, Spastic, run by Seoul National University Hospital 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 5 inclusion and 5 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 1 May 2023. 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?
Migration index (time frame: 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388422, which also lists 1 linked publication.
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 May 2023.