Children with Cerebral PalsyEVSP-ANAT-CPNCT06131320
Brain Lesion and Visuospatial Impairment in CP Child
An observational study of Children with Cerebral Palsy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Children with Cerebral Palsy
- What is being tested?
- PVSE Test and Cerebral MRI
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 2 Apr 2024
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children coming for out-patient consultation at the paediatric rehabilitation unit of the Hospices Civils de Lyon for a CP diagnosis
Who may be able to join
- 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
Who cannot join
- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric rehabilitation unit of the Hospices Civils de Lyon
Bron, 69677
About this study
Official title: Visuo-spatial Profile in Children with Cerebral Palsy Born At Term or Not and Anatomical Correlation
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.
- Conditions
- Children with Cerebral Palsy
- Being tested
- PVSE Test, Cerebral MRI
- Keywords
- Cerebral Palsy, child, visuo-spatial disorder, brain lesion
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVSE TestDiagnostic test
Completion of the PVSE test
Cerebral MRIOther
Cerebral MRI scan
| Study group | Role | What they receive |
|---|---|---|
| CP child | Not described Receives: Diagnostic Test: PVSE Test; Other: Cerebral MRI | |
| CP child with a PVSE test and a cerebral MRI performed during his/her follow-up | Not described Receives: Diagnostic Test: PVSE Test; Other: Cerebral MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children with Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131320
- Sponsor's protocol ID
- 69HCL23_1053
- Acronym
- EVSP-ANAT-CP
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuo-spatial Profile in Children with Cerebral Palsy Born At Term or Not and Anatomical Correlation
- ClinicalTrials.gov ID
- NCT06131320
- Acronym / sponsor ID
- EVSP-ANAT-CP / 69HCL23_1053
- Conditions
- Children with Cerebral Palsy
- Keywords
- Cerebral Palsy, child, visuo-spatial disorder, brain lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP child | – | Diagnostic Test: PVSE Test, Other: Cerebral MRI |
| CP child with a PVSE test and a cerebral MRI performed during his/her follow-up | – | Diagnostic Test: PVSE Test, Other: Cerebral MRI |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children coming for out-patient consultation at the paediatric rehabilitation unit of the Hospices Civils de Lyon for a CP diagnosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVSE TestCompletion of the PVSE test | Diagnostic test | CP child, CP child with a PVSE test and a cerebral MRI performed during his/her follow-up |
| Cerebral MRICerebral MRI scan | Other | CP child, CP child with a PVSE test and a cerebral MRI performed during his/her follow-up |
Primary outcome
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.)
Time frame: At the inclusion
Using normative values of PVSE test, we assess pathological measure inferior outlier limits and subnormal measure below the lower quartile limit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children with Cerebral Palsy, run by Hospices Civils de Lyon at 1 site in France.
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 4 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 8 Nov 2024. 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 France. 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?
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.) (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.