Cerebral Palsy
Conditions
Brief summary
Single Blinded, Randomized-control tiral, Multicenter clinical trial
Interventions
DEVICEHip protection orthosis
Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
Sponsors
Korea Health Industry Development Institute
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration index | 6 months | Hip AP radiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale | 6 months | measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain. |
| 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed