- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634292
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study (PRALOC)
November 12, 2020 updated by: University Hospital, Grenoble
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
Study Overview
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 Type
Observational
Enrollment (Anticipated)
84
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy children and children with cerebral palsy
Description
Inclusion Criteria:
- normal walking
For children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months
Exclusion Criteria:
- medical problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with cerebral palsy 7-9 years
21 children
|
EEG + walking task + auditory task
|
|
Children with cerebral palsy 10-12 years
21 children
|
EEG + walking task + auditory task
|
|
Healthy children 7-9 years
21 children
|
EEG + walking task + auditory task
|
|
Healthy children 10-12 years
21 children
|
EEG + walking task + auditory task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural correlates during dual tasking in children
Time Frame: 2 years
|
EEG, locomotion parameters, cognitive performances
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2020
Primary Completion (ANTICIPATED)
September 30, 2022
Study Completion (ANTICIPATED)
September 30, 2022
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (ACTUAL)
November 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 12, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 38RC20.067
- 2020-A00470-39 (OTHER: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.