NCT04033289

Brief Summary

Single Blinded, Randomized-control tiral, Multicenter clinical trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

July 24, 2019

Last Update Submit

August 23, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Migration index

    Hip AP radiography

    6 months

Secondary Outcomes (5)

  • 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

  • Child Health Index of Life with Disabilities (CPCHILD)

    6 months

Study Arms (2)

experimental group

EXPERIMENTAL
Device: Hip protection orthosis

control group

NO INTERVENTION

Interventions

Hip protection orthosisDEVICE

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

experimental group

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 36331502DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Juseok Ryu, Phd

    professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 26, 2019

Study Start

August 1, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)