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Cerebral PalsyNCT01903616

A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan

An observational study of Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the longitudinal course of developmental patterns in movement and participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan. Read more about this study

Who is it for?
Ages 3 months to 12 years
Conditions the study is for
Cerebral Palsy
How many people
172 participants
Where
1 siteTaiwan
Study dates
Jul 2009to Aug 2020
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 3 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with cerebral palsy

Who may be able to join

  • diagnosis of CP

Who cannot join

  • presence of a progressive neurological disorder or a severe concurrent illness or disease not typically associated with CP, such as traumatic brain injury or active pneumonia

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

This study investigates the longitudinal course of developmental patterns in movement and participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan. Additionally, the predictors in the initial stage in determining the final developmental patterns in movement and participation in life activities MPLA of these children will be identified.

Read the detailed description

Most researches investigated the longitudinal study of functions in adolescent or adult with CP, however, few researches investigate these functions in children with CP. Knowledge of these developmental patterns in movement and participation in life activities MPLA may be helpful in understanding, anticipating, and managing the problems of these children. We hypothesize that the course of developmental patterns in MPLA of young children with CP evolves with their age. This study investigates the longitudinal course of developmental patterns in MPLA of young children with CP in Taiwan. This study includes a validity and reliability study and a prospective longitudinal study of young children with CP over one-year. This study will be executed in 4 years and a validity and reliability study in the first year.

Conditions
Cerebral Palsy
Medical subject headings
Cerebral Palsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of speech and acoustic variables in 6, 12 and 24 months

    Measurement of speech and acoustic variables

    Measured: baseline, 6m, 12m, 24 m

Secondary outcomes (8)

  1. Change of range of motion (ROM) in 6, 12 and 24 months

    Measurement of ROM

    Measured: baseline, 6m, 12m, 24 m

  2. Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months

    Measurement of PBS

    Measured: baseline, 6m, 12m, 24 m

  3. Change of spinal Alignment and Range of Motion Measure(SARROM) in 6, 12 and 24 months

    Measurement of SARROM

    Measured: baseline, 6m, 12m, 24 m

  4. Change of modified ashworth scale(MAS) in 6, 12 and 24 months

    Measurement of MAS

    Measured: baseline, 6m, 12m, 24 m

  5. Change of cerebral palsy quality of life (CPQOL) in 6, 12 and 24 months

    Measurement of CPQOL

    Measured: baseline, 6m, 12m, 24 m

  6. Change of TNO-AZL Preschool children Quality of Life (TAPQOL)in 6, 12 and 24 months

    Measurement of TAPQOL

    Measured: baseline, 6m, 12m, 24 m

  7. Change of Children Assessment of Participation and Enjoyment (CAPE) in 6, 12 and 24 months

    Measurement of CAPE

    Measured: baseline, 6m, 12m, 24 m

  8. Change of Gross motor function measure (GMFM) in 6, 12 and 24 months

    Measurement of GMFM

    Measured: baseline, 6m, 12m, 24 m

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2013 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2020
  4. Study completionAug 2020

Resources

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
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903616
Sponsor's protocol ID
NSC 98-2314-B-182-006-MY3
Status last verified
Jan 2020
First submitted
17 Jul 2013
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 1 inclusion and 1 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 of speech and acoustic variables in 6, 12 and 24 months (time frame: baseline, 6m, 12m, 24 m). 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 NCT01903616.

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 24 Aug 2020.

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