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

Status

Completed

Conditions

Intervention / Treatment

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

  • Korea, Republic of
    • 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
Device: Hip protection orthosis
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.

Sponsor

Seoul National University Hospital

Collaborators

Korea Health Industry Development Institute

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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