Child DevelopmentPRALOCNCT04634292
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study
An observational study of Child Development, run by University Hospital, Grenoble.
Trial summary
Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- EEG
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to 30 Sep 2022
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children and children with cerebral palsy
Who may be able to join
- normal walking
- For children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months
Who cannot join
- medical problem
About this study
Official title: Processus Attentionnels impliqués Dans la Locomotion Chez l'Enfant à développement Typique et l'Enfant Atteint de Paralysie cérébrale : Une étude EEG.
Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking
Read the detailed description
Children will walk at their preferred speed on a treadmill. During dual tasking, they will listen to animals cries and will have to count the number of specified animals cries.
- Conditions
- Child Development
- Being tested
- EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGBehavioural
EEG + walking task + auditory task
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy 7-9 years | 21 children Receives: Behavioral: EEG | |
| Children with cerebral palsy 10-12 years | 21 children Receives: Behavioral: EEG | |
| Healthy children 7-9 years | 21 children Receives: Behavioral: EEG | |
| Healthy children 10-12 years | 21 children Receives: Behavioral: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural correlates during dual tasking in children
EEG, locomotion parameters, cognitive performances
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study startNov 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634292
- Sponsor's protocol ID
- 38RC20.067
- Other IDs
- 2020-A00470-39
- Acronym
- PRALOC
- Status last verified
- Nov 2020
- First submitted
- 3 Sep 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processus Attentionnels impliqués Dans la Locomotion Chez l'Enfant à développement Typique et l'Enfant Atteint de Paralysie cérébrale : Une étude EEG.
- ClinicalTrials.gov ID
- NCT04634292
- Acronym / sponsor ID
- PRALOC / 38RC20.067
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 18 Nov 2020 (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.
Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking
Detailed description
Children will walk at their preferred speed on a treadmill. During dual tasking, they will listen to animals cries and will have to count the number of specified animals cries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy 7-9 years | – | Behavioral: EEG21 children |
| Children with cerebral palsy 10-12 years | – | Behavioral: EEG21 children |
| Healthy children 7-9 years | – | Behavioral: EEG21 children |
| Healthy children 10-12 years | – | Behavioral: EEG21 children |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children and children with cerebral palsy
Key inclusion criteria (2 listed)
- normal walking
- For children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months
Key exclusion criteria (1 listed)
- medical problem
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 |
|---|---|---|
| EEGEEG + walking task + auditory task | Behavioural | Children with cerebral palsy 10-12 years, Children with cerebral palsy 7-9 years, Healthy children 10-12 years, Healthy children 7-9 years |
Primary outcome
Neural correlates during dual tasking in children
Time frame: 2 years
EEG, locomotion parameters, cognitive performances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by University Hospital, Grenoble.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Neural correlates during dual tasking in children (time frame: 2 years). 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 18 Nov 2020.