Cerebral Palsy
Conditions
Keywords
Cerebral palsy, GMFM-66, PEDI
Brief summary
This study is designed to assess effectiveness, safety and cost-utility of conventional rehabilitation and traditional Korean medicine conjugated rehabilitation on children with cerebral palsy.
Detailed description
1. Survey 1. An interview survey on baseline * Basic characteristics * Cause of cerebral palsy * Accompanied disorders * Health problems * Operation history * Drug-taking * Rehabilitation treatment * Korean medicine treatment * Health functional food * Medical care cost 2. An interview survey on 26th and 52nd weeks * Accompanied disorders * Health problems 3. A weekly tracking survey * Health problems * Therapeutic change * Medical care cost * Quality of life 2. Assessment for function development on baseline, 26th and 52nd weeks * Gross Motor Function Classification System (GMFCS) * Gross Motor Function Measure-66 (GMFM-66) * Pediatric Evaluation of Disability Inventory (PEDI)
Interventions
acupuncture and herbal drugs
Sponsors
Korea Health Industry Development Institute
Korean Medicine Hospital of Pusan National University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 78 Months
Healthy volunteers
No
Inclusion criteria
* Children with cerebral palsy * Age from 6 to 78 months * whose guardian consent to the present study
Exclusion criteria
* who had an orthopedic operation due to cerebral palsy * who has congenital muscular disease, hereditary disease, or progressive central nervous system diseases * who suffers from severe diseases (ie, cancer, severe heart disease, severe infectious disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on PEDI scores at week 26 and 52 | Baseline, Week 26, Week 52 | The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions. |
| Change from baseline on GMFM-66 scores at week 26 and 52 | Baseline, Week 26, Week 52 | The GMFM-66 includes 66 items identified through Rasch analysis, which, together, best describe gross motor function in children with cerebral palsy of varying abilities. |
Secondary
| Measure | Time frame |
|---|---|
| Change of severity from baseline on accompanied disorders and health problems at week 24 and 52 | Baseline, Week 26, Week 52 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economy evaluation | Baseline, Week 26, Week 52 | Direct and indirect medical care cost, Labor productivity of family |
| Number of Participants with Serious and Non-Serious Adverse Events | up to 52 weeks | — |
| Change from baseline on height and weight at week 24 and 52 | Baseline, Week 26, Week 52 | — |
Countries
South Korea
Outcome results
None listed