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CompletedNCT04033289Updated Aug 24, 2022

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

An interventional study of Hip protection orthosis in Cerebral Palsy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
All
01

Study summary

Single Blinded, Randomized-control tiral, Multicenter clinical trial

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Conditions studied

  • Cerebral Palsy
03

In context

Hip Dislocation

141 studies on the registry are indexed under Hip Dislocation; 34 are open to participants now.

This study's enrollment of 66 is below the median of 90 across 91 interventional studies indexed under Hip Dislocation.

Browse Hip Dislocation studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • GMFCE level IV or V in the Cerebral palsy
  • age from 1 to 10

Exclusion criteria

Exclusion Criteria:

  • History of hip joint surgery
  • Botulinum toxin injection to hip muscle past 3 months or expected in our study duration
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    experimental group

    Device: Hip protection orthosis

  • No intervention
    control group

Interventions

  • DeviceHip protection orthosis

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

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What researchers measure

Primary outcomes

  1. Migration index

    Hip AP radiography

    Time frame: 6 months

Secondary outcomes

  1. Cobb's angle (')

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

    Time frame: 6 months

  2. Range of motion of hip joint (')

    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.

    Time frame: 6 months

  3. Visual analog scale

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

    Time frame: 6 months

  4. Likert scale (score)

    measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.

    Time frame: immediately after wearing orthosis

  5. Child Health Index of Life with Disabilities (CPCHILD)

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

    Time frame: 6 months

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
08

References and documents

Publications

  • 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. Erratum In: JAMA Netw Open. 2022 Dec 1;5(12):e2247506. doi: 10.1001/jamanetworkopen.2022.47506. PubMed 36331502 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04033289
Lead sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
Responsible party
Ju Seok Ryu (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 26, 2019
Start date
Aug 1, 2019
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Aug 24, 2022

Study contacts

Juseok Ryu, Phd
study chair · professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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