Back to resultsThe Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
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:
- age from 1 to 15
- Patients with severe neuromuscular disease
- Patients who agreed to participate in the study
- Hip dislocation more than 10% (migration index)
Exclusion Criteria:
- If do not agree with the study
- Those who are determined to be difficult to participate under the judgment of the research director
- History of hip joint surgery
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental 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
NCT04483050
First Posted
July 20, 2020
Last Updated
November 22, 2022
Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
1. Study Identification
Unique Protocol Identification Number
NCT04483050
Brief Title
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
Official Title
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 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
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
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
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age from 1 to 15
Patients with severe neuromuscular disease
Patients who agreed to participate in the study
Hip dislocation more than 10% (migration index)
Exclusion Criteria:
If do not agree with the study
Those who are determined to be difficult to participate under the judgment of the research director
History of hip joint surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juseok Ryu, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
State/Province
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
We'll reach out to this number within 24 hrs