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NCT Number: NCT02223741

Observational Study of the 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 month–78 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan national University Yangsan Hospital, Yangsan, Gyeongsangnam-do, South Korea

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About this study

  • Survey
  • 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
  • An interview survey on 26th and 52nd weeks
  • Accompanied disorders
  • Health problems
  • A weekly tracking survey
  • Health problems
  • Therapeutic change
  • Medical care cost
  • Quality of life
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Korean medical treatment

Other

acupuncture and herbal drugs

Primary outcomes

  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 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

    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

Sponsors and collaborators

Lead sponsor

Korean Medicine Hospital of Pusan National University

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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