Condition or disease | Intervention/treatment | Phase |
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Cerebral Palsy | Device: flexible thoracolumbar brace | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial |
Actual Study Start Date : | September 3, 2018 |
Actual Primary Completion Date : | July 2, 2020 |
Actual Study Completion Date : | July 2, 2020 |
Arm | Intervention/treatment |
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Experimental: Prospective, single-arm trial |
Device: flexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
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Ages Eligible for Study: | 3 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul national university bundang hospital | |
Seongnam-si, Bundang-gu, Korea, Republic of, 13354 |
Study Chair: | JUSEOK RYU, PhD | Seoul National University Bundang Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | June 5, 2019 | ||||
First Posted Date ICMJE | July 9, 2019 | ||||
Last Update Posted Date | July 21, 2020 | ||||
Actual Study Start Date ICMJE | September 3, 2018 | ||||
Actual Primary Completion Date | July 2, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change of scoliosis [ Time Frame: 6months ] Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy | ||||
Official Title ICMJE | The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial | ||||
Brief Summary | The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Cerebral Palsy | ||||
Intervention ICMJE | Device: flexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
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Study Arms ICMJE | Experimental: Prospective, single-arm trial
Intervention: Device: flexible thoracolumbar brace
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
14 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 2, 2020 | ||||
Actual Primary Completion Date | July 2, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 3 Years to 15 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04012125 | ||||
Other Study ID Numbers ICMJE | B-1805/471-003 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ju Seok Ryu, Seoul National University Hospital | ||||
Study Sponsor ICMJE | Seoul National University Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Seoul National University Hospital | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |