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出境医 / 临床实验 / The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

Study Description
Brief Summary:
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: flexible thoracolumbar brace Not Applicable

Study Design
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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
Arms and Interventions
Arm Intervention/treatment
Experimental: Prospective, single-arm trial Device: flexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain of the back (thorax) [ Time Frame: 6 months ]
    Patients check the scale through the visual analog scale

  2. change of quality of life (aspect of the parents) [ Time Frame: 6 months ]
    Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GMFCS level III, IV, V of the Cerebral palsy
  • 20-45 degree of Cobb's angle

Exclusion Criteria:

  • less than 20 degree or more than 45 degree of Cobb's angle
  • Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
  • Acute lumbar pain
  • Fixed scoliosis
Contacts and Locations

Locations
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Korea, Republic of
Seoul national university bundang hospital
Seongnam-si, Bundang-gu, Korea, Republic of, 13354
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: JUSEOK RYU, PhD Seoul National University Bundang Hospital
Tracking Information
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
 (submitted: July 8, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Pain of the back (thorax) [ Time Frame: 6 months ]
    Patients check the scale through the visual analog scale
  • change of quality of life (aspect of the parents) [ Time Frame: 6 months ]
    Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace
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
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Device: flexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
Study Arms  ICMJE Experimental: Prospective, single-arm trial
Intervention: Device: flexible thoracolumbar brace
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019) 		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:

  • GMFCS level III, IV, V of the Cerebral palsy
  • 20-45 degree of Cobb's angle

Exclusion Criteria:

  • less than 20 degree or more than 45 degree of Cobb's angle
  • Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
  • Acute lumbar pain
  • Fixed scoliosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ju Seok Ryu, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: JUSEOK RYU, PhD Seoul National University Bundang Hospital
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

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