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CompletedNCT02223741Updated Feb 25, 2020

Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

An observational study in Cerebral Palsy, sponsored by Korean Medicine Hospital of Pusan National University. Completed at 6 sites in Korea, Republic of. Open to participants aged 6 Months to 78 Months. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Korean Medicine Hospital of Pusan National University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
6 Months to 78 Months
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Cerebral Palsy

Keywords

  • Cerebral palsy
  • GMFM-66
  • PEDI
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 207 is above the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Korean Medicine Hospital of Pusan National University is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 78 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population will be selected from rehabilitation clinics for children

Inclusion criteria

  • Children with cerebral palsy
  • Age from 6 to 78 months
  • whose guardian consent to the present study

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and 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

    Other: Korean medical treatment

  • Conventional rehabilitation

    those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies

Interventions

  • OtherKorean medical treatment

    acupuncture and herbal drugs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 26, Week 52

  2. 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.

    Time frame: Baseline, Week 26, Week 52

Secondary outcomes

  1. Change of severity from baseline on accompanied disorders and health problems at week 24 and 52

    Time frame: Baseline, Week 26, Week 52

Other outcomes

  1. Economy evaluation

    Direct and indirect medical care cost, Labor productivity of family

    Time frame: Baseline, Week 26, Week 52

  2. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: up to 52 weeks

  3. Change from baseline on height and weight at week 24 and 52

    Time frame: Baseline, Week 26, Week 52

07

Study locations

6 sites
  • Pusan national University Yangsan Hospital
    Yangsan, Gyeongnam, Korea, Republic of
  • Pusan National University Hospital
    Busan, 602-739, Korea, Republic of
  • Seongmo-i Oriental Medical Clinic
    Daegu, 563-4, Korea, Republic of
  • Haema Oriental Medical Clinic
    Seoul, 1605-5, Korea, Republic of
  • Heoyoungjin Oriental Medical Clinic
    Seoul, 936-7, Korea, Republic of
  • Dong-Eui University Korean Medical Hospital
    Ulsan, 479-7, Korea, Republic of
08

References and documents

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. PubMed 27267182 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02223741
Lead sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Health Industry Development Institute
Responsible party
Young Ju Yun (Associate Professor, Korean Medicine Hospital of Pusan National University) — Principal investigator
First posted
Aug 22, 2014
Start date
Aug 2014
Primary completion
May 11, 2017
Completion
May 11, 2017
Last update
Feb 25, 2020

Study contacts

Young-Ju Yun, MD, Ph D.
principal investigator · Pusan National University Korean Medicine Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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