NCT01903603

Brief Summary

The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
12 months 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
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2016

Enrollment Period

4.8 years

First QC Date

July 17, 2013

Last Update Submit

September 7, 2017

Conditions

Cerebral Palsy

Keywords

cerebral palsymulti-modal brain techniquesMRIKinematicmotor control

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months

    fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)

    baseline, 6 months, 12 months

Secondary Outcomes (4)

  • Change from baseline of kinematic analysis in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months

    6 months and 12 months

  • Change from baseline of movement and participation for CP in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of severity for CP patients in 6 months and 12 months

    baseline, 6 months, 12 months

Study Arms (2)

Healthy Children

Inclusion criteria for healthy children were as follows: ages of 4-20 y/o ; good cognition and cooperation; and healthy children.

CP subjects

Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 4-20 years old.

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

CP and healthy children

You may qualify if:

  • (1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants

You may not qualify if:

  • (1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection

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, PhD

    Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

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

August 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 11, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)