Back to resultsThe Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hip protection orthosis
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- GMFCE level IV or V in the Cerebral palsy
- age from 1 to 10
Exclusion Criteria:
- History of hip joint surgery
- Botulinum toxin injection to hip muscle past 3 months or expected in our study duration
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
Outcomes
Primary Outcome Measures
Migration index
Hip AP radiography
Secondary Outcome Measures
Cobb's angle (')
using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
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.
Visual analog scale
measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Likert scale (score)
measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
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.
Full Information
NCT ID
NCT04033289
First Posted
July 24, 2019
Last Updated
August 23, 2022
Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
1. Study Identification
Unique Protocol Identification Number
NCT04033289
Brief Title
The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
Official Title
The Clinical Efficacy of Hip Protection Orthosis for The Protection of Hip Dislocation in Patients With Severe Cerebral Palsy, Single Blinded, Randomized-control Trial, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Single Blinded, Randomized-control tiral, Multicenter clinical trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Hip protection orthosis
Intervention Description
Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
Primary Outcome Measure Information:
Title
Migration index
Description
Hip AP radiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cobb's angle (')
Description
using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
Time Frame
6 months
Title
Range of motion of hip joint (')
Description
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.
Time Frame
6 months
Title
Visual analog scale
Description
measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Time Frame
6 months
Title
Likert scale (score)
Description
measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
Time Frame
immediately after wearing orthosis
Title
Child Health Index of Life with Disabilities (CPCHILD)
Description
measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
GMFCE level IV or V in the Cerebral palsy
age from 1 to 10
Exclusion Criteria:
History of hip joint surgery
Botulinum toxin injection to hip muscle past 3 months or expected in our study duration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juseok Ryu, Phd
Organizational Affiliation
professor
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36331502
Citation
Kim BR, Yoon JA, Han HJ, Yoon YI, Lim J, Lee S, Cho S, Shin YB, Lee HJ, Suh JH, Jang J, Beom J, Park Y, Choi JH, Ryu JS. Efficacy of a Hip Brace for Hip Displacement in Children With Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2240383. doi: 10.1001/jamanetworkopen.2022.40383. Erratum In: JAMA Netw Open. 2022 Dec 1;5(12):e2247506.
Results Reference
derived
Learn more about this trial
The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
We'll reach out to this number within 24 hrs