Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

February 23, 2020 updated by: Young Ju Yun, Korean Medicine Hospital of Pusan National University

An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population will be selected from rehabilitation clinics for children

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
acupuncture and herbal drugs
Conventional rehabilitation
those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 26, Week 52
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.
Baseline, Week 26, Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
Time Frame: Baseline, Week 26, Week 52
Baseline, Week 26, Week 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economy evaluation
Time Frame: Baseline, Week 26, Week 52
Direct and indirect medical care cost, Labor productivity of family
Baseline, Week 26, Week 52
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: up to 52 weeks
up to 52 weeks
Change from baseline on height and weight at week 24 and 52
Time Frame: Baseline, Week 26, Week 52
Baseline, Week 26, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

May 11, 2017

Study Completion (Actual)

May 11, 2017

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP_conjugated rehabilitation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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