Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Interventions
- Other: Korean medical treatment
- Registration Number
- NCT02223741
- Lead Sponsor
- Korean Medicine Hospital of Pusan National University
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Children with cerebral palsy
- Age from 6 to 78 months
- whose guardian consent to the present study
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Korean medicine conjugate rehabilitation Korean medical treatment those with more than 30 days of herbal drugs or more than 12 times of acupuncture (Korean medical treatment) within six months in addition to conventional rehabilitation
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Change of severity from baseline on accompanied disorders and health problems at week 24 and 52 Baseline, Week 26, Week 52
Trial Locations
- Locations (6)
Heoyoungjin Oriental Medical Clinic
🇰🇷Seoul, Korea, Republic of
Pusan national University Yangsan Hospital
🇰🇷Yangsan, Gyeongnam, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Haema Oriental Medical Clinic
🇰🇷Seoul, Korea, Republic of
Seongmo-i Oriental Medical Clinic
🇰🇷Daegu, Korea, Republic of
Dong-Eui University Korean Medical Hospital
🇰🇷Ulsan, Korea, Republic of