Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy
An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy
1 other identifier
observational
207
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2017
CompletedFebruary 25, 2020
February 1, 2020
2.8 years
August 20, 2014
February 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline on GMFM-66 scores at week 26 and 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.
Baseline, Week 26, Week 52
Change from baseline on PEDI scores at week 26 and 52
The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.
Baseline, Week 26, Week 52
Secondary Outcomes (1)
Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
Baseline, Week 26, Week 52
Other Outcomes (3)
Economy evaluation
Baseline, Week 26, Week 52
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
Study Arms (2)
Korean medicine conjugate rehabilitation
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
Conventional rehabilitation
those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies
Interventions
Eligibility Criteria
Population will be selected from rehabilitation clinics for children
You may qualify if:
- Children with cerebral palsy
- Age from 6 to 78 months
- whose guardian consent to the present study
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pusan national University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
Seongmo-i Oriental Medical Clinic
Daegu, 563-4, South Korea
Haema Oriental Medical Clinic
Seoul, 1605-5, South Korea
Heoyoungjin Oriental Medical Clinic
Seoul, 936-7, South Korea
Dong-Eui University Korean Medical Hospital
Ulsan, 479-7, South Korea
Related Publications (1)
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.
PMID: 27267182DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Ju Yun, MD, Ph D.
Pusan National University Korean Medicine Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 22, 2014
Study Start
August 1, 2014
Primary Completion
May 11, 2017
Study Completion
May 11, 2017
Last Updated
February 25, 2020
Record last verified: 2020-02