Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223741
• Other study ID #: CP_conjugated rehabilitation
• Status: Completed
• Start date: August 2014
• Est. completion date: May 11, 2017

Study information

• Verified date: February 2020
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: May 11, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 78 Months

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Korean medical treatment
acupuncture and herbal drugs

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Seongmo-i Oriental Medical Clinic	Daegu
Korea, Republic of	Haema Oriental Medical Clinic	Seoul
Korea, Republic of	Heoyoungjin Oriental Medical Clinic	Seoul
Korea, Republic of	Dong-Eui University Korean Medical Hospital	Ulsan
Korea, Republic of	Pusan national University Yangsan Hospital	Yangsan	Gyeongnam

Sponsors (2)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economy evaluation	Direct and indirect medical care cost, Labor productivity of family	Baseline, Week 26, Week 52
Other	Number of Participants with Serious and Non-Serious Adverse Events		up to 52 weeks
Other	Change from baseline on height and weight at week 24 and 52		Baseline, Week 26, Week 52
Primary	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.	Baseline, Week 26, Week 52
Primary	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.	Baseline, Week 26, Week 52
Secondary	Change of severity from baseline on accompanied disorders and health problems at week 24 and 52		Baseline, Week 26, Week 52