Cerebral PalsyNCT02223741
Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Korean Medicine Hospital of Pusan National University at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 6 to 78 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Korean medical treatment
- How many people
- 207 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Aug 2014to 11 May 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 78 months
- All sexes
- No healthy volunteers
- Child
Study population: Population will be selected from rehabilitation clinics for children
Who may be able to join
- Children with cerebral palsy
- Age from 6 to 78 months
- whose guardian consent to the present study
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Pusan National University Hospital
Busan, 602-739
Seongmo-i Oriental Medical Clinic
Daegu, 563-4
Haema Oriental Medical Clinic
Seoul, 1605-5
Heoyoungjin Oriental Medical Clinic
Seoul, 936-7
Dong-Eui University Korean Medical Hospital
Ulsan, 479-7
Pusan national University Yangsan Hospital
Yangsan, Gyeongsangnam-do
About this study
Official title: 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.
Read the detailed description
- 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)
- Conditions
- Cerebral Palsy
- Being tested
- Korean medical treatment
- Keywords
- Cerebral palsy, GMFM-66, PEDI
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean medical treatmentOther
acupuncture and herbal drugs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Korean medical treatment | |
| Conventional rehabilitation | those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 26, Week 52
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.
Measured: Baseline, Week 26, Week 52
Secondary outcomes (1)
Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
Measured: Baseline, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Young Ju Yun, Korean Medicine Hospital of Pusan National University
- Investigators
- Young-Ju Yun, MD, Ph D., Principal investigator, Pusan National University Korean Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223741
- Sponsor's protocol ID
- CP_conjugated rehabilitation
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02223741
- Acronym / sponsor ID
- CP_conjugated rehabilitation
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, GMFM-66, PEDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- Aug 2014 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean medicine conjugate rehabilitation | – | Other: Korean medical treatmentthose 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 |
| Conventional rehabilitation | – | –those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies |
Who may qualify
- Ages
- 6 to 78 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Population will be selected from rehabilitation clinics for children
Key inclusion criteria (3 listed)
- Children with cerebral palsy
- Age from 6 to 78 months
- whose guardian consent to the present study
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean medical treatmentacupuncture and herbal drugs | Other | Korean medicine conjugate rehabilitation |
Primary outcome
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.
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.
1 secondary outcome
Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
Time frame: Baseline, Week 26, Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 27267182Yoo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Ju Yun, MD, Ph D. principal investigator
Pusan National University Korean Medicine Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Korean Medicine Hospital of Pusan National University at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on GMFM-66 scores at week 26 and 52 (time frame: Baseline, Week 26, Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.