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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033289
• Other study ID #: E-1906/546/002
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single Blinded, Randomized-control tiral, Multicenter clinical trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hip Dislocation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration index	Hip AP radiography	6 months
Secondary	Cobb's angle (')	using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.	6 months
Secondary	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.	6 months
Secondary	Visual analog scale	measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.	6 months
Secondary	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.	immediately after wearing orthosis
Secondary	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.	6 months