NCT06131320

Brief Summary

Children with cerebral palsy (CP) show varying degrees of motor impairment and movement disorders whose perceptive-visual contribution has yet to be established. The literature reports that children with CP have more frequent neuro-visual disorders. The link between the location and size of the brain lesion and neurovisual symptomatology has yet to be explored. In this retrospective clinical data study, we will investigate in children with PC whether there is an anatomo-clinical correlation between visuo-spatial disorders is the brain injury of interest to the dorsal visual pathway. We will explore the volume of grey and white matter parietal involvement. To test visuo-spatial disorders, we will use the PVSE (Visuo-Spatial Elementary Perception) test which does not require motor skills or language and is therefore suitable for children with a PC. This test will make it possible to better identify the deficit or deficits in order to adapt an early remediation. It could serve as a reference for comparing several pathologies/etiologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

November 9, 2023

Last Update Submit

November 7, 2024

Conditions

Keywords

Cerebral Palsy, child, visuo-spatial disorder, brain lesion

Outcome Measures

Primary Outcomes (1)

  • PVSE test results: total score and 8 sub-scores (length perception, size perception, angle comparison, midline localization, position perception, position selection, occipital score and parietal score.)

    Using normative values of PVSE test, we assess pathological measure inferior outlier limits and subnormal measure below the lower quartile limit

    At the inclusion

Study Arms (2)

CP child

Diagnostic Test: PVSE TestOther: Cerebral MRI

CP child with a PVSE test and a cerebral MRI performed during his/her follow-up

Diagnostic Test: PVSE TestOther: Cerebral MRI

Interventions

PVSE TestDIAGNOSTIC_TEST

Completion of the PVSE test

CP childCP child with a PVSE test and a cerebral MRI performed during his/her follow-up

Cerebral MRI scan

CP childCP child with a PVSE test and a cerebral MRI performed during his/her follow-up

Eligibility Criteria

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

Children coming for out-patient consultation at the paediatric rehabilitation unit of the Hospices Civils de Lyon for a CP diagnosis

You may qualify if:

  • Male or female aged 4 to 18 yo
  • With a CP diagnosis
  • With PVSE test completion during his/her regular follow-up
  • With a cerebral MRI scan during his/her regular follow-up

You may not qualify if:

  • \- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric rehabilitation unit of the Hospices Civils de Lyon

Bron, 69677, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion

April 2, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations