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Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02223741
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Young Ju Yun, Korean Medicine Hospital of Pusan National University

Tracking Information
First Submitted Date August 20, 2014
First Posted Date August 22, 2014
Last Update Posted Date February 25, 2020
Actual Study Start Date August 2014
Actual Primary Completion Date May 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2014)
  • Change from baseline on GMFM-66 scores at week 26 and 52 [ Time Frame: 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 [ Time Frame: Baseline, Week 26, Week 52 ]
    The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2014)
Change of severity from baseline on accompanied disorders and health problems at week 24 and 52 [ Time Frame: Baseline, Week 26, Week 52 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 20, 2014)
  • Economy evaluation [ Time Frame: 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 [ Time Frame: up to 52 weeks ]
  • Change from baseline on height and weight at week 24 and 52 [ Time Frame: Baseline, Week 26, Week 52 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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)
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Population will be selected from rehabilitation clinics for children
Condition Cerebral Palsy
Intervention Other: Korean medical treatment
acupuncture and herbal drugs
Study Groups/Cohorts
  • 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
    Intervention: Other: Korean medical treatment
  • Conventional rehabilitation
    those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 23, 2020)
207
Original Estimated Enrollment
 (submitted: August 20, 2014)
300
Actual Study Completion Date May 11, 2017
Actual Primary Completion Date May 11, 2017   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 78 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02223741
Other Study ID Numbers CP_conjugated rehabilitation
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Young Ju Yun, Korean Medicine Hospital of Pusan National University
Study Sponsor Korean Medicine Hospital of Pusan National University
Collaborators Korea Health Industry Development Institute
Investigators
Principal Investigator: Young-Ju Yun, MD, Ph D. Pusan National University Korean Medicine Hospital
PRS Account Korean Medicine Hospital of Pusan National University
Verification Date February 2020