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Clinical Trials/NCT04033289
NCT04033289
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country66 target enrollmentAugust 1, 2019
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ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Seoul National University Hospital
Enrollment
66
Locations
1
Primary Endpoint
Migration index
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Single Blinded, Randomized-control tiral, Multicenter clinical trial

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
October 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ju Seok Ryu

Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Migration index

Time Frame: 6 months

Hip AP radiography

Secondary Outcomes

  • Child Health Index of Life with Disabilities (CPCHILD)(6 months)
  • Cobb's angle (')(6 months)
  • Range of motion of hip joint (')(6 months)
  • Visual analog scale(6 months)
  • Likert scale (score)(immediately after wearing orthosis)

Study Sites (1)

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