Cognitive and Postural Activities of Prematurely Born Children

Mobility Clinical Trial

— COGNIPOST  

Official title:

Interdependency Between Cognitive and Postural Activities in Prematurely Born Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04275895
• Other study ID #: 2019-A02385-52
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Attention Deficit
• Attention Deficit Disorder with Hyperactivity
• Mobility
• Postural Activity

Intervention

Behavioral:
• Evaluation of different attention or/and postural activities
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

Locations

Country	Name	City	State
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 minutes
Primary	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	4 minutes 30 secondes
Primary	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	4 minutes 30 secondes
Primary	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)	12 minutes