NCT01903616

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 24, 2020

Status Verified

January 1, 2020

Enrollment Period

11.1 years

First QC Date

July 17, 2013

Last Update Submit

August 21, 2020

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

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

    Measurement of speech and acoustic variables

    baseline, 6m, 12m, 24 m

Secondary Outcomes (8)

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

    baseline, 6m, 12m, 24 m

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

    baseline, 6m, 12m, 24 m

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

    baseline, 6m, 12m, 24 m

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

    baseline, 6m, 12m, 24 m

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

    baseline, 6m, 12m, 24 m

  • +3 more secondary outcomes

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with cerebral palsy

You may qualify if:

  • diagnosis of CP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chia-Ling Chen, MD,PhD

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

July 1, 2009

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 24, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)