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

NCT ID: NCT04033289

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-10-31

Brief Summary

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Single Blinded, Randomized-control tiral, Multicenter clinical trial

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental group

Group Type EXPERIMENTAL

Hip protection orthosis

Intervention Type DEVICE

Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hip protection orthosis

Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juseok Ryu, Phd

Role: STUDY_CHAIR

professor

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Kim BR, Yoon JA, Han HJ, Yoon YI, Lim J, Lee S, Cho S, Shin YB, Lee HJ, Suh JH, Jang J, Beom J, Park Y, Choi JH, Ryu JS. Efficacy of a Hip Brace for Hip Displacement in Children With Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2240383. doi: 10.1001/jamanetworkopen.2022.40383.

Reference Type DERIVED
PMID: 36331502 (View on PubMed)

Other Identifiers

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E-1906/546/002

Identifier Type: -

Identifier Source: org_study_id

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