NCT04483050

Brief Summary

The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

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

Study Start

First participant enrolled

February 5, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

July 20, 2020

Last Update Submit

November 22, 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 (1)

experimental group

EXPERIMENTAL
Device: Hip protection orthosis

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 - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age from 1 to 15
  • Patients with severe neuromuscular disease
  • Patients who agreed to participate in the study
  • Hip dislocation more than 10% (migration index)

You may not qualify if:

  • If do not agree with the study
  • Those who are determined to be difficult to participate under the judgment of the research director
  • History of hip joint surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Juseok Ryu, PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

February 5, 2020

Primary Completion

March 11, 2021

Study Completion

March 11, 2021

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations

KR(1)