Attention DeficitCOGNIPOSTNCT04275895
Cognitive and Postural Activities of Prematurely Born Children
A study testing Evaluation of different attention or/and postural activities in people with Attention Deficit and Mobility, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Prematurely born children (PC) have academic difficulties related to poorer attention capabilities. Additionally, they often show excessive mobility, quoted as agitation. Some consider it could be related to poorer postural control and impaired perception of gravity vertical. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit, Mobility, Postural Activity
- What is being tested?
- Evaluation of different attention or/and postural activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2020to 15 Aug 2024
- Phase
- Interventional
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children born before 37 weeks gestation or at term and routinely followed for their prematurity in the follow-up clinic of the Maternite Regionale Universitaire and healthy term born children recruited after information in different schools of Meurthe-et-Moselle
- Child whose holders of parental authority have received complete information on the organization of the research and have signed the consent
Who cannot join
- Severe hypotrophy at birth defined by a weight z-score below -2.
- Children with developmental, cognitive, visual or motor disability preventing the execution of the tests
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, 54035
About this study
Official title: Interdependency Between Cognitive and Postural Activities in Prematurely Born Children
Prematurely born children (PC) have academic difficulties related to poorer attention capabilities. Additionally, they often show excessive mobility, quoted as agitation. Some consider it could be related to poorer postural control and impaired perception of gravity vertical. But, this excessive mobility could also be an unconscious way for PC to improve their attention performance. The aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC versus term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed with the use of a mobile versus a classic school chair. Secondly, participants will have to position a stick vertically to measure their perception of vertical gravity. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement) will be studied during the execution of three different attention tasks at different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture.
Read the detailed description
Prematurely born children (PC) at school age have academic difficulties related to poorer attention capabilities. Posner (1990) described three distinct attention functions: Alert (to maintain a vigilance state), Orientation (to select the relevant information) and Inhibition (to resist distraction). Additionally, teachers and parents are often concerned because they move more than term born children; this excessive mobility being often quoted as agitation. Some consider it would be related to a poorer postural control potentially explained by a poorer perception of vertical gravity. Another explanation is that this mobility could be an unconscious way for PC to increase their arousal level to improve their attention performance. Therefore, the aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC and term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed evaluating Alert and Inhibition, and its evolution when the infants will use a mobile school chair, compared to a classic school chair. Secondly, participants will perform a test of perception of vertical gravity in which they will have to position a stick vertically. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement measured with a forced plate) will be studied during the execution of three different attention tasks: a vigilance task, a visual search task or an inhibition task at two different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture. Success rate and reaction time will be analyzed for all the attention tasks as well as the angle errors in degree between the stick orientation given by the children and the real vertical. Furthermore, the sway path, the surface area and the entropy of the displacement of CP will be computed to determine respectively the mobility, the precision of the postural control and the attention allocated to the posture of these children.
- Conditions
- Attention Deficit, Mobility, Postural Activity
- Being tested
- Evaluation of different attention or/and postural activities
- Keywords
- Prematurely born children, Attention function, Posture, Mobility
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of different attention or/and postural activitiesBehavioural
- The children, equipped with a head-mounted display (HMD), will indicate as quickly as possible the direction of a fish that can be surrounded by congruent or not flankers (Inhibition) and/or preceded by signal (Alert)
- The children, equipped with a HMD and a joystick, will vertically turn a randomly inclined stick
- The children will stand on a force plate watching a cartoon, gazing a fixation cross or eyes closed
- The children, equipped with an augmented reality headset, will perform 2 levels of difficulty of 3 attention tasks standing on a force plate:
- They will click as quickly as possible when they see a frog among successively appearing animals (vigilance task)
- They will give the name of an animal appearing at one of the windows displayed (visual search task)
- They will count the number of yellow lions oriented to the right among several animals of different color and direction (inhibition task)
- Growth trajectory will be retrieved from health booklet
| Study group | Role | What they receive |
|---|---|---|
| Prematurely born Children | Experimental | Evaluation of different attention or/and postural activities :
1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic).
2. Child perception of the vertical compared to the real vertical
3. Evaluation of the posture of the child during different visual conditions
4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty Receives: Behavioral: Evaluation of different attention or/and postural activities |
| Term born Children | Active comparator | Evaluation of different attention or/and postural activities
1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic).
2. Child perception of the vertical compared to the real vertical
3. Evaluation of the posture of the child during different visual conditions
4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty Receives: Behavioral: Evaluation of different attention or/and postural activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and Reaction time (in msec) to the response to visual target (fish) direction
40 trials of fishes displayed for a maximum of 2500 msec to the left or the right hand side, by chair condition (classic, mobile), where the child has to give as quickly as possible the direction of the fish
Measured: 8 minutes
Angle error (in degree) between the stick orientation given by the child and the real vertical
3 trials of randomly inclined stick by position (sitting, lying to the right, lying to the left) where the child has to turn the stick vertically
Measured: 4 minutes 30 secondes
Sway path (distance traveled by the center of pressure - CP -) and surface area (ellipse covering 90% of the center of pressure displacement)
3 x 30 secondes of record on the force plate by standing condition (eyes opened watching a cartoon, gazing a fixation cross, eyes closed) where the child has to stay up without move their feet
Measured: 4 minutes 30 secondes
Sway path (distance traveled by the center of pressure - CP -), surface area (ellipse covering 90% of the center of pressure displacement) and entropy (index of regularity of postural oscillations)
2 x 1 minutes of record on the force plate by level of difficulty (easy, difficult) and by task (vigilance task, visual search task, inhibition task)
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start11 Sep 2020
- Primary completion30 Dec 2023
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention DeficitStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Attention performance of a group of prematurely born children will be compared on a classical school chair and a mobile school chair. The same comparison will be made for a group of term born children. The perception of the Vertical gravity of the two groups will be evaluated in sitting position, lying to the right side and lying the left side. The postural control of the two groups will be evaluated standing on a force plate in three conditions : eyes opened watching a cartoon, eyes opened gazing a fixation cross on the wall and eyes closed. The postural control of the two groups will be measured during the execution of three different attentional tasks. For each task, two levels of difficulty will be tested. Finally, growth trajectory from birth will be analysed as a confounding factor.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275895
- Sponsor's protocol ID
- 2019-A02385-52
- Acronym
- COGNIPOST
- Status last verified
- Aug 2024
- First submitted
- 17 Feb 2020
- Last updated
- 19 Aug 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdependency Between Cognitive and Postural Activities in Prematurely Born Children
- ClinicalTrials.gov ID
- NCT04275895
- Acronym / sponsor ID
- COGNIPOST / 2019-A02385-52
- Conditions
- Attention Deficit, Mobility, Postural Activity
- Keywords
- Prematurely born children, Attention function, Posture, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 19 Feb 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.
Prematurely born children (PC) have academic difficulties related to poorer attention capabilities. Additionally, they often show excessive mobility, quoted as agitation. Some consider it could be related to poorer postural control and impaired perception of gravity vertical. But, this excessive mobility could also be an unconscious way for PC to improve their attention performance. The aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC versus term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed with the use of a mobile versus a classic school chair. Secondly, participants will have to position a stick vertically to measure their perception of vertical gravity. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement) will be studied during the execution of three different attention tasks at different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture.
Detailed description
Prematurely born children (PC) at school age have academic difficulties related to poorer attention capabilities. Posner (1990) described three distinct attention functions: Alert (to maintain a vigilance state), Orientation (to select the relevant information) and Inhibition (to resist distraction). Additionally, teachers and parents are often concerned because they move more than term born children; this excessive mobility being often quoted as agitation. Some consider it would be related to a poorer postural control potentially explained by a poorer perception of vertical gravity. Another explanation is that this mobility could be an unconscious way for PC to increase their arousal level to improve their attention performance. Therefore, the aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC and term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed evaluating Alert and Inhibition, and its evolution when the infants will use a mobile school chair, compared to a classic school chair. Secondly, participants will perform a test of perception of vertical gravity in which they will have to position a stick vertically. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement measured with a forced plate) will be studied during the execution of three different attention tasks: a vigilance task, a visual search task or an inhibition task at two different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture. Success rate and reaction time will be analyzed for all the attention tasks as well as the angle errors in degree between the stick orientation given by the children and the real vertical. Furthermore, the sway path, the surface area and the entropy of the displacement of CP will be computed to determine respectively the mobility, the precision of the postural control and the attention allocated to the posture of these children.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Attention performance of a group of prematurely born children will be compared on a classical school chair and a mobile school chair. The same comparison will be made for a group of term born children. The perception of the Vertical gravity of the two groups will be evaluated in sitting position, lying to the right side and lying the left side. The postural control of the two groups will be evaluated standing on a force plate in three conditions : eyes opened watching a cartoon, eyes opened gazing a fixation cross on the wall and eyes closed. The postural control of the two groups will be measured during the execution of three different attentional tasks. For each task, two levels of difficulty will be tested. Finally, growth trajectory from birth will be analysed as a confounding factor.
| Arm | Type | Receives |
|---|---|---|
| Prematurely born Children | Experimental | Behavioral: Evaluation of different attention or/and postural activitiesEvaluation of different attention or/and postural activities : 1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic). 2. Child perception of the vertical compared to the real vertical 3. Evaluation of the posture of the child during different visual conditions 4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty |
| Term born Children | Active comparator | Behavioral: Evaluation of different attention or/and postural activitiesEvaluation of different attention or/and postural activities 1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic). 2. Child perception of the vertical compared to the real vertical 3. Evaluation of the posture of the child during different visual conditions 4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children born before 37 weeks gestation or at term and routinely followed for their prematurity in the follow-up clinic of the Maternite Regionale Universitaire and healthy term born children recruited after information in different schools of Meurthe-et-Moselle
- Child whose holders of parental authority have received complete information on the organization of the research and have signed the consent
Key exclusion criteria (2 listed)
- Severe hypotrophy at birth defined by a weight z-score below -2.
- Children with developmental, cognitive, visual or motor disability preventing the execution of the tests
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 |
|---|---|---|
| Evaluation of different attention or/and postural activities1. The children, equipped with a head-mounted display (HMD), will indicate as quickly as possible the direction of a fish that can be surrounded by congruent or not flankers (Inhibition) and/or preceded by signal (Alert) 2. The children, equipped with a HMD and a joystick, will vertically turn a randomly inclined stick 3. The children will stand on a force plate watching a cartoon, gazing a fixation cross or eyes closed 4. The children, equipped with an augmented reality headset, will perform 2 levels of difficulty of 3 attention tasks standing on a force plate: * They will click as quickly as possible when they see a frog among successively appearing animals (vigilance task) * They will give the name of an animal appearing at one of the windows displayed (visual search task) * They will count the number of yellow lions oriented to the right among several animals of different color and direction (inhibition task) 5. Growth trajectory will be retrieved from health booklet | Behavioural | Prematurely born Children, Term born Children |
Primary outcome
Accuracy and Reaction time (in msec) to the response to visual target (fish) direction
Time frame: 8 minutes
40 trials of fishes displayed for a maximum of 2500 msec to the left or the right hand side, by chair condition (classic, mobile), where the child has to give as quickly as possible the direction of the fish
Angle error (in degree) between the stick orientation given by the child and the real vertical
Time frame: 4 minutes 30 secondes
3 trials of randomly inclined stick by position (sitting, lying to the right, lying to the left) where the child has to turn the stick vertically
Sway path (distance traveled by the center of pressure - CP -) and surface area (ellipse covering 90% of the center of pressure displacement)
Time frame: 4 minutes 30 secondes
3 x 30 secondes of record on the force plate by standing condition (eyes opened watching a cartoon, gazing a fixation cross, eyes closed) where the child has to stay up without move their feet
Sway path (distance traveled by the center of pressure - CP -), surface area (ellipse covering 90% of the center of pressure displacement) and entropy (index of regularity of postural oscillations)
Time frame: 12 minutes
2 x 1 minutes of record on the force plate by level of difficulty (easy, difficult) and by task (vigilance task, visual search task, inhibition task)
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 19 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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?
A study testing Evaluation of different attention or/and postural activities in people with Attention Deficit and Mobility, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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 19 Aug 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?
Accuracy and Reaction time (in msec) to the response to visual target (fish) direction (time frame: 8 minutes). The study lists 4 primary outcomes in all. 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 19 Aug 2024.