- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04483050
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
November 22, 2022 updated by: Ju Seok Ryu, Seoul National University Hospital
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seongnam-si, Gyeonggi-do
-
Gyeonggi-do, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental group
|
Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migration index
Time Frame: 6 months
|
Hip AP radiography
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cobb's angle (')
Time Frame: 6 months
|
using radiography, expressed by degree from 0' to 180'.
The closer to 0', the better the value.
|
6 months
|
Range of motion of hip joint (')
Time Frame: 6 months
|
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.
|
6 months
|
Visual analog scale
Time Frame: 6 months
|
measure the pain expressed by score from 0 to 10.
The closer to 10, the higher the pain.
|
6 months
|
Likert scale (score)
Time Frame: immediately after wearing orthosis
|
measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
|
immediately after wearing orthosis
|
Child Health Index of Life with Disabilities (CPCHILD)
Time Frame: 6 months
|
measure the quality of life expressed by score from 0 to 100.
The higher the quality of life.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Juseok Ryu, PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 5, 2020
Primary Completion (ACTUAL)
March 11, 2021
Study Completion (ACTUAL)
March 11, 2021
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 20, 2020
First Posted (ACTUAL)
July 23, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 22, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2002/594-305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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