Clinical trial NCT02223741: Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy
Official title: An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
GMFM-66
PEDI
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2014-08-22
Enrollment: 207
Sex: ALL
Minimum age (years): 6
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be selected from rehabilitation clinics for children

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline on GMFM-66 scores at week 26 and 52
timeFrame: Baseline, Week 26, Week 52
measure: Change from baseline on PEDI scores at week 26 and 52
timeFrame: Baseline, Week 26, Week 52
Secondary outcomes:
measure: Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
timeFrame: Baseline, Week 26, Week 52
Other outcomes:
measure: Economy evaluation
timeFrame: Baseline, Week 26, Week 52
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: up to 52 weeks
measure: Change from baseline on height and weight at week 24 and 52
timeFrame: Baseline, Week 26, Week 52
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan national University Yangsan Hospital
state: Gyeongnam
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Seongmo-i Oriental Medical Clinic
city: Seoul
country: Korea, Republic of
facility: Haema Oriental Medical Clinic
city: Seoul
country: Korea, Republic of
facility: Heoyoungjin Oriental Medical Clinic
city: Ulsan
country: Korea, Republic of
facility: Dong-Eui University Korean Medical Hospital
Study officials:
affiliation: Pusan National University Korean Medicine Hospital
name: Young-Ju Yun, MD, Ph D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoo JE, Yun YJ, Shin YB, Kim NK, Kim SY, Shin MJ, Yu SA. Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy. BMC Complement Altern Med. 2016 Jun 8;16:172. doi: 10.1186/s12906-016-1161-6.