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

N/ACompletedNCT04033289

Seoul National University Hospital66 enrolled

Overview

Single Blinded, Randomized-control tiral, Multicenter clinical trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Hip protection orthosisDEVICE

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Migration index

Hip AP radiography

Time frame: 6 months

Secondary Outcomes

Cobb's angle (')

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

Time frame: 6 months

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

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

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

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

Data from ClinicalTrials.gov

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