CHILDIMOTNCT05300100
Exploration of Sensory-motor Representations in Children of Typical Development Aged 5 to 8
A study testing sensorimotor activities in people with CHILD, run by Centre Hospitalier de Lens at 5 sites in France.
Trial summary
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- CHILD
- What is being tested?
- sensorimotor activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Mar 2022to 27 Jan 2023
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 5 to 8
- Child enrolled in accordance with his age
- No sensory abnormality identified
- No neurodevelopmental abnormality identified
Who cannot join
- Child not affiliated to a social security scheme.
- Refusal to participate by parents and / or child
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Psychomotor therapist' offices
Amiens, 80000
Hospital Dr Schaffner
Lens, 62307
Hôpital Saint Vincent
Lille, 59000
Hospital Sambre Avesnois
Maubeuge, 59600
Psychomotor therapist' offices
Wavrin, 59136
About this study
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.
Read the detailed description
The early coupling of perception and action makes it possible to build the sensorimotor representations, necessary for the functions of anticipation, adaptation and learning which will allow a harmonious development of motor skills throughout ontogenesis. One of the current hypotheses to explain the learning disorders detected in elementary school is a defect in the development of sensorimotor representations. Our study therefore aims to assess the quality of sensorimotor representations in typically developing children aged 5 to 8 years, using a motor imaging protocol, conventionally used in the literature in adults and patients. child. This motor imagery protocol consists of comparing the time taken by the subject to perform a given action and the time taken to imagine the action he has just performed. More precisely, the mental chronometry paradigm, based on the similarity or the difference between the two durations, makes it possible to assess the robustness of sensorimotor representations. While this isochrony is widely reported in the literature in adults, developmental studies describe onset around 9-10 years of age. Currently there is a lack of data to know the construction of these sensorimotor representations in younger children, especially during the transition to primary school. The originality of our protocol lies in two points: 1. the proposed tasks are particularly suited to young children and 2. the subject himself times his performance in the two situations: action carried out and action imagined. The duration of the experience will last 1 hour per participant in a single session.
- Conditions
- CHILD
- Being tested
- sensorimotor activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorimotor activitiesBehavioural
The activities chosen involve either the whole body or specific parts such as the hand to grasp or perform graphic tests.
- Trial 1 : Straightening: passage from sitting to sitting.
- Trial 2 : Movement with difficulty of balance: heel-toe walking
- Trial 3 : Movement with difficulty of balance with a structured visual environment: heel-toe walk in a contrasting fabric decoration to increase the impact of visual flow
- Trial 4 : Move to a target, 5 m away
- Trial 5 : Graphics: drawing of a tree. This test requires spatial skills and the establishment of median space in written transcription.
- Trial 6 : Manual entry: collection of 12 small cubes arranged in an arc in front of the child using one hand, the choice of which will be left to the child.
All of these tests will be offered according to a so-called "interlaced" protocol, that is to say, each execution of an action will be followed by an action simulation, and this alternation will be repeated 5 times for each task. .
| Study group | Role | What they receive |
|---|---|---|
| Activities | Experimental | The duration of the experience will last 1 hour per participant in a single session.
The proposed actions were chosen from a very large sensorimotor repertoire of activities in everyday life for a child aged 5 to 8.
The activities chosen involve either the whole body or specific parts such as the hand to grasp or perform graphic tests. Receives: Behavioral: sensorimotor activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.
The primary outcome measure is the change in the gross motor imagery score. This is defined as the average of the motor imagery scores for each of the tasks performed individually;
The motor imagery score for each individual IMtaskX task is calculated as follows:
IMtaskX = | (DrtaskX - DitaskX) / DrtaskX |
DrtaskX being the real measured duration of the movements performed DitaskX being the imagined duration of the movements performed Each task will be performed 5 times by each subject. DrtaskX and DitaskX are therefore an average of the 5 repetitions of the task.
With regard to interpretation, the further the motor imagery index is from 0, the greater the difference between the duration of the imagined movement and the duration of the movement carried out, in other words the poorer the internal representations of the movement. 'action.
Measured: Day 1
Secondary outcomes (4)
Study the link between the construction of internal representations and overall sensorimotor skills according to age.
Correlation between global motor imagery score and global MABC-II score by age.
IMtaskX = | (DrtaskX - DitaskX) / DrtaskX |
DrtaskX being the real measured duration of the movements performed DitaskX being the imagined duration of the movements performed
Measured: Day 1
Study the link between the motor imagery score of each individual task and overall sensorimotor skills by age
Correlation between the motor imagery score of each individual task and the overall MABC-II score by age.
IMtaskX = | (DrtaskX - DitaskX) / DrtaskX |
DrtaskX being the real measured duration of the movements performed DitaskX being the imagined duration of the movements performed
Measured: Day 1
Study the link between the global motor imagery score, that is to say the construction of internal representations, and each of the 3 specific sensorimotor skills assessed via the MABC-II test according to age.
Correlation between the global motor imagery score and the individual score of each of the 3 categories of the MABC-II test according to age.
IMtaskX = | (DrtaskX - DitaskX) / DrtaskX |
DrtaskX being the real measured duration of the movements performed DitaskX being the imagined duration of the movements performed
Measured: Day 1
Study the link between the motor imagery score of each individual task and each of the 3 sensorimotor skills assessed via the MABC-II test according to age.
Correlation between the motor imagery score of each individual task and the individual score of each of the 3 disciplines of the MABC-II test according to age.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start4 Mar 2022
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHILDStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Lens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Marie-Bertille DEHOUCK, Dr, Principal investigator, Hospital of Lens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300100
- Sponsor's protocol ID
- 2021-01
- Acronym
- IMOT
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Sensory-motor Representations in Children of Typical Development Aged 5 to 8
- ClinicalTrials.gov ID
- NCT05300100
- Acronym / sponsor ID
- IMOT / 2021-01
- Conditions
- CHILD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier de LensUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 29 Mar 2022 (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.
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.
Detailed description
The early coupling of perception and action makes it possible to build the sensorimotor representations, necessary for the functions of anticipation, adaptation and learning which will allow a harmonious development of motor skills throughout ontogenesis. One of the current hypotheses to explain the learning disorders detected in elementary school is a defect in the development of sensorimotor representations. Our study therefore aims to assess the quality of sensorimotor representations in typically developing children aged 5 to 8 years, using a motor imaging protocol, conventionally used in the literature in adults and patients. child. This motor imagery protocol consists of comparing the time taken by the subject to perform a given action and the time taken to imagine the action he has just performed. More precisely, the mental chronometry paradigm, based on the similarity or the difference between the two durations, makes it possible to assess the robustness of sensorimotor representations. While this isochrony is widely reported in the literature in adults, developmental studies describe onset around 9-10 years of age. Currently there is a lack of data to know the construction of these sensorimotor representations in younger children, especially during the transition to primary school. The originality of our protocol lies in two points: 1. the proposed tasks are particularly suited to young children and 2. the subject himself times his performance in the two situations: action carried out and action imagined. The duration of the experience will last 1 hour per participant in a single session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activities | Experimental | Behavioral: sensorimotor activitiesThe duration of the experience will last 1 hour per participant in a single session. The proposed actions were chosen from a very large sensorimotor repertoire of activities in everyday life for a child aged 5 to 8. The activities chosen involve either the whole body or specific parts such as the hand to grasp or perform graphic tests. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child aged 5 to 8
- Child enrolled in accordance with his age
- No sensory abnormality identified
- No neurodevelopmental abnormality identified
Key exclusion criteria (2 listed)
- Child not affiliated to a social security scheme.
- Refusal to participate by parents and / or child
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 |
|---|---|---|
| sensorimotor activitiesThe activities chosen involve either the whole body or specific parts such as the hand to grasp or perform graphic tests. * Trial 1 : Straightening: passage from sitting to sitting. * Trial 2 : Movement with difficulty of balance: heel-toe walking * Trial 3 : Movement with difficulty of balance with a structured visual environment: heel-toe walk in a contrasting fabric decoration to increase the impact of visual flow * Trial 4 : Move to a target, 5 m away * Trial 5 : Graphics: drawing of a tree. This test requires spatial skills and the establishment of median space in written transcription. * Trial 6 : Manual entry: collection of 12 small cubes arranged in an arc in front of the child using one hand, the choice of which will be left to the child. All of these tests will be offered according to a so-called "interlaced" protocol, that is to say, each execution of an action will be followed by an action simulation, and this alternation will be repeated 5 times for each task. . | Behavioural | Activities |
Primary outcome
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.
Time frame: Day 1
The primary outcome measure is the change in the gross motor imagery score. This is defined as the average of the motor imagery scores for each of the tasks performed individually; The motor imagery score for each individual IMtaskX task is calculated as follows: IMtaskX = | (DrtaskX - DitaskX) / DrtaskX | DrtaskX being the real measured duration of the movements performed DitaskX being the imagined duration of the movements performed Each task will be performed 5 times by each subject. DrtaskX and DitaskX are therefore an average of the 5 repetitions of the task. With regard to interpretation, the further the motor imagery index is from 0, the greater the difference between the duration of the imagined movement and the duration of the movement carried out, in other words the poorer the internal representations of the movement. 'action.
4 secondary outcomes
Study the link between the construction of internal representations and overall sensorimotor skills according to age.
Time frame: Day 1
Study the link between the motor imagery score of each individual task and overall sensorimotor skills by age
Time frame: Day 1
Study the link between the global motor imagery score, that is to say the construction of internal representations, and each of the 3 specific sensorimotor skills assessed via the MABC-II test according to age.
Time frame: Day 1
Study the link between the motor imagery score of each individual task and each of the 3 sensorimotor skills assessed via the MABC-II test according to age.
Time frame: Day 1
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 24 Mar 2023.
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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.
Marie-Bertille DEHOUCK, Dr principal investigator
Hospital of Lens
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensorimotor activities in people with CHILD, run by Centre Hospitalier de Lens at 5 sites 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 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years. (time frame: Day 1). 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 24 Mar 2023.