A Longitudinal Study of Movement and Participation in Lif... | NCT01903616

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

NCT01903616

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Aug 24, 2020Actual

Enrollment

172Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Aug 2020Actual

Completion Date

Aug 2020Actual

First Submitted Date

Jul 17, 2013

First Submission Date that Met QC Criteria

Jul 17, 2013

First Posted Date

Jul 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2020

Last Update Posted Date

Aug 24, 2020Actual

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change of range of motion (ROM) in 6, 12 and 24 months	Measurement of ROM	baseline, 6m, 12m, 24 m
Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months	Measurement of PBS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of CP

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children with cerebral palsy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chia-Ling Chen, MD,PhD	Chang Gung Memorial Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital		Taoyuan		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided