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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

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.

Condition or disease Intervention/treatment
Cerebral Palsy Other: Korean medical 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)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy
Actual Study Start Date : August 2014
Actual Primary Completion Date : May 11, 2017
Actual Study Completion Date : May 11, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Economy evaluation [ Time Frame: Baseline, Week 26, Week 52 ]
    Direct and indirect medical care cost, Labor productivity of family

  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 78 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be selected from rehabilitation clinics for children
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223741


Locations
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Korea, Republic of
Pusan national University Yangsan Hospital
Yangsan, Gyeongnam, Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Seongmo-i Oriental Medical Clinic
Daegu, Korea, Republic of, 563-4
Haema Oriental Medical Clinic
Seoul, Korea, Republic of, 1605-5
Heoyoungjin Oriental Medical Clinic
Seoul, Korea, Republic of, 936-7
Dong-Eui University Korean Medical Hospital
Ulsan, Korea, Republic of, 479-7
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Korea Health Industry Development Institute
Investigators
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Principal Investigator: Young-Ju Yun, MD, Ph D. Pusan National University Korean Medicine Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Young Ju Yun, Associate Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02223741    
Other Study ID Numbers: CP_conjugated rehabilitation
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Young Ju Yun, Korean Medicine Hospital of Pusan National University:
Cerebral palsy
GMFM-66
PEDI
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases