The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04033289
• Collaborator: Korea Health Industry Development Institute (Other)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Single Blinded, Randomized-control tiral, Multicenter clinical trial

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Device: Hip protection orthosis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

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.
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. Migration index [6 months]

   Hip AP radiography

Secondary Outcome Measures

1. Cobb's angle (') [6 months]

   using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.

2. Range of motion of hip joint (') [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.

3. Visual analog scale [6 months]

   measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.

4. Likert scale (score) [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.

5. Child Health Index of Life with Disabilities (CPCHILD) [6 months]

   measure the quality of life expressed by score from 0 to 100. The higher the quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Hospital
• Korea Health Industry Development Institute

Investigators

• Study Chair: Juseok Ryu, Phd, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ju Seok Ryu, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04033289
• Other Study ID Numbers: E-1906/546/002
• First Posted: Jul 26, 2019
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hip Dislocation; Cerebral Palsy

Study Results

No Results Posted as of Aug 24, 2022