The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
Not Applicable
Completed
- Conditions
- Cerebral Palsy
- Interventions
- Device: Hip protection orthosis
- Registration Number
- NCT04033289
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Single Blinded, Randomized-control tiral, Multicenter clinical trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Hip protection orthosis -
- Primary Outcome Measures
Name Time Method Migration index 6 months Hip AP radiography
- Secondary Outcome Measures
Name Time Method Child Health Index of Life with Disabilities (CPCHILD) 6 months measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
Cobb's angle (') 6 months using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
Range of motion of hip joint (') 6 months 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.
Visual analog scale 6 months measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Likert scale (score) immediately after wearing orthosis measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of