Cerebral Palsy
Conditions
Keywords
Cerebral palsy, Brace, Scoliosis
Brief summary
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
Interventions
DEVICEflexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* GMFCS level III, IV, V of the Cerebral palsy * 20-45 degree of Cobb's angle
Exclusion criteria
* less than 20 degree or more than 45 degree of Cobb's angle * Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis * Acute lumbar pain * Fixed scoliosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of scoliosis | 6months | Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain of the back (thorax) | 6 months | Patients check the scale through the visual analog scale |
| change of quality of life (aspect of the parents) | 6 months | Parent of the patients assessed caregiver experience with neuromuscular disease before and 6-month after wearing FLEXpine brace |
Countries
South Korea
Outcome results
None listed