Child DevelopmentMove&LearnNCT06030310
Effects of Application of a Motor Programme on Neurological Maduration in Children
A study testing The developmental Exercise Programme of INPP in people with Child Development, run by Fundació Universitària del Bages at 1 site in Spain.
Trial summary
The persistence of primitive reflexes in school-age children can affect neuromotor maturation. Some studies link the persistence of primitive reflexes with specific learning difficulties, low academic performance, neurodevelopmental disorders, and behavioral problems. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- The developmental Exercise Programme of INPP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2023to 30 Jun 2026
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children enrolled in the second grade of the selected schools
- Age between 7 and 9 years
Who cannot join
- Children unable to perform the exercises due to physical and/or cognitive limitations
- Those unable to consistently attend the therapy sessions (with an absence rate of more than 80%) or have physical limitations
- Children who cannot understand the language and therefore cannot complete the questionnaires and tests to be conducted
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Marta Not Monegal
Manresa, Barcelona, 08243
Marta Not Monegal, MSc, 656366323, mnot@umanresa.cat
About this study
Official title: Effects of the Application of a Motor Programme Throughout an Academic Year on the Neurological Maduration of a Sample of 2nd Grade Children of Primary Schools in Catalonia
The persistence of primitive reflexes in school-age children can affect neuromotor maturation. Some studies link the persistence of primitive reflexes with specific learning difficulties, low academic performance, neurodevelopmental disorders, and behavioral problems. There are studies that suggest introducing intervention programs to help integrate the activity of these reflexes. The objective of this study is to assess the effects of implementing a motor program on the neurologic maturation of second-grade children throughout an academic year in Catalonia.
A prospective experimental longitudinal and randomized pre-post study will be conducted with two groups: Non Intervention group and intervention group, known as the INPP Movement Program Group (with daily application of the motor program), lasting for one academic year (from September '23 to June '24). Currently, a feasibility study will be conducted at a school in Valls, with a sample of 50 children, and data will be collected at the beginning and end of the academic year. The study will analyze primitive reflexes, motor skills related to balance and coordination, oculo-motor skills, and the risk of presenting dyslexia. Once the feasibility study is completed, the same study with appropriate modifications will be carried out in different schools across Catalonia during the academic year 2024 - 2025 (yet to be determined).
Read the detailed description
Introduction: In a study conducted in Catalonia in 2020, it was found that 18,3% of school-age children between 5 and 17 years old had some neurodevelopmental disorder. There are studies that relate neurodevelopment to neuromotor immaturity and the presence of primitive reflexes. Others studies associate primitive reflexes with: attention deficit (ADD), attention deficit/hyperactivity disorder (ADHD), motor disorders and cognitive performance disorders.
Neuromotor immaturity, as defined by The Institute for Neuro-Physiological Psychology (INPP), involves the retention of a set of primitive reflexes beyond the first year of life and the absence and/or underdevelopment of postural reflexes beyond three years of age.
Primitive reflexes promote movement, and through movement, these reflexes gradually integrate. As a result, primitive reflexes are replaced by more mature postural reactions that are used throughout life. Properly developed postural reactions form the basis of good posture, balance, and coordination. However, in older age, some primitive reflexes may remain unintegrated. Regardless of a child's age, the presence of these reflexes indicates neuromotor immaturity.
Some studies describe primitive reflexes as one of the contributing factors to neurodevelopmental disorders, affecting the harmonious motor development of the child. Immature motor skills have been linked to learning difficulties such as reading and writing problems, difficulties in numerical skills, dyslexia, and behavioral problems. The presence of retained primitive reflexes is more common in children with neurodevelopmental disorders, and it acts as a barrier to learning.
There is evidence linking the presence of primitive reflexes to visual skills in children aged 6 to 14 years. Visual skills can influence reading and writing due to the connection between visual skills and hand-eye coordination. These visual skills, along with balance, coordination, and postural control, are essential for fixing the gaze and reading and writing fluently.
Studies have shown that by reducing the presence of primitive reflexes through motor activity, learning difficulties can also be reduced, leading to improved academic performance in students.
In 1996, INPP developed a school program intended to be applied collectively in classrooms with the aim of reducing neuromotor immaturity in students aged 7 and above. This school program designed by INPP consists of two parts: the INPP Test Battery for schools and the INPP motor exercise program. The INPP Test Battery for schools comprises a set of tests to evaluate the presence of unintegrated primitive reflexes and psychomotor skills (primarily related to aspects of balance and coordination). The INPP motor exercise program consists of a set of exercises designed to replicate the developmental movements of infants during early stages of neurodevelopment. This assessment and therapeutic tool can be used by various professionals, but it is specifically designed for teachers and other professionals involved in education and child development to identify and treat children displaying signs of neuromotor immaturity. This tool has not been validated in English, Spanish, or Catalan.
Some studies have applied motor programs to reduce the presence of primitive reflexes and have shown improvements in the maturation of primitive reflexes. These programs are proposed as possible ways to address neuromotor immaturity.
There is limited evidence on the relationship between motor function, primitive reflexes, and learning impairments. A review on these three aspects, published in 2022, recommends further research on the topic.
Hypothesis: Implementing the INPP school program in classrooms for second-grade students in Catalan schools will enable the assessment and integration of remaining primitive reflexes, leading to improvements in neuro-motor maturation, oculomotor skills, and a reduction in the incidence of risk of dyslexia.
Objectives: After completing Phase 1, which involved a viability test of selected evaluation tools (April 2023), the objective is to initiate Phase 2:
Phase 2: Prospective experimental longitudinal non-randomized study with two groups: Non Intervention group and intervention group, known as the INPP Movement Program Group (with daily application of the motor program). The study will be conducted in second-grade students at Claret School in Valls. Both groups will undergo the INPP school program assessment battery and specific tests to evaluate oculomotor skills and the risk of dyslexia at the beginning and end of the school year. The INPP Movement Program Group will perform the INPP motor program for 15 minutes daily throughout the academic year, while the Non Intervention Group will continue their regular school curriculum without the specific motor program but may receive it in the following academic year (2024-25) if significant benefits for students are demonstrated.
This school program only excludes those children who have difficulties in performing the exercises (e.g., due to a motor impairment) or those who cannot understand the instructions and thus cannot be evaluated with the pre-program motor assessments (e.g., newcomers who don't understand the language).
Phase 3: Prospective experimental longitudinal study in different schools in Catalonia, each with a significant sample size, to assess neuromotor maturation pre- and post-application of the INPP school program in relation to different variables: primitive reflexes, oculomotor skills, and the risk of dyslexia in children.
Ethical Aspects:
This project has undergone evaluation by an ethics committee, and a favorable opinion was obtained in November 2022.
The legal guardians of the study participants will be informed through an information sheet prior to their inclusion and through an informative meeting that will take place at the schools. These guardians will sign the informed consent sheet. As this study involves child participants, the informed consent will be signed by the legal guardian.
Due to the nature of the study and its methodological phases, it is not anticipated that there will be any health risks to the participants during its execution. Moreover, those who wish to do so can withdraw from the study at any time without any negative repercussions.
At the end of the study, schools and/or families that wish to do so will receive a summary of the obtained results and publications resulting from the study, upon request to the principal investigator.
In the next school year, the option of applying the school program will be offered to the control group that did not receive it during the study.
All data will be coded, meaning each participant will be assigned a code, and it will be impossible to identify participants with the given responses, ensuring confidentiality. At all times, the General Data Protection Regulation (EU) 2016/679, the Data Protection Act (GDPR), Organic Law 3/2018, December 5, on personal data protection and guarantee of digital rights, and Organic Law 1/1982, May 5, on the protection of the civil right to honor, personal and family privacy, and one's own image will be respected. Additionally, the guidelines of the Code of Ethics of the College of Physiotherapists and the Declaration of Helsinki on human rights in medical research will be followed.
The data will be stored by the principal investigator in the OneDrive of the Fundació Universitària del Bages Campus Manresa of the UVic-UCC, linked to the project. The coded database will only be accessible to the research team members who need to analyze the results through a personalized and temporary link to the OneDrive of the Fundació Universitària del Bages Campus Manresa of the Uvic-UCC or on the laptop safeguarded by the principal investigator.
No recordings will be made as they are not essential for the study.
- Conditions
- Child Development
- Being tested
- The developmental Exercise Programme of INPP
- Keywords
- Primitive reflex, Motor function, Oculomotor function, Risk of presenting dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The developmental Exercise Programme of INPPOther
The INPP school motor program consists of a series of developmental movements based on the normal movements of a child in their first year of life. Exercises must be performed as slow as possible and must be repeated for at least six weeks.
Once the children have performed a set of movements, a new set will be presented for practice in a more complex position.
The exercises are done on the floor and aid in developing:
Proper alignment of the head with the body, trunk stability. Balance and coordination. The ability to use both sides of the body and upper and lower parts independently.
Muscle tone in prone and supine position. Hand-eye coordination and visual skills
| Study group | Role | What they receive |
|---|---|---|
| INPP Movement Program Group | Experimental | The INPP Movement Program Group will consist on a group of children aged between 7 and 9 years old enrolled in the second grade class of a catalan school that will participate in the school motor program provided by the Institute of Neuro-Physiology Psychology (INPP). This program consists of exercises that replicate the developmental movements of babies. Each day, a set of specific exercises will be performed, it will be practiced for 6 weeks and replaced by another set of exercises. They will be conducted for 15 minutes daily throughout the entire academic year. Receives: Other: The developmental Exercise Programme of INPP |
| Non Intervention Group | No intervention | Children aged between 7 and 9 years old enrolled in the second grade at a catalan school. Students in the Non Intervention Group will continue with their regular academic school year without any additional intervention. If any student from the INPP Movement Program Group chooses not to participate in the study, they will join the class of the Non Intervention Group during the time when their peers are engaged in the school motor program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflex status
To assess the neuromotor maturation pre and post application of the INPP school programme in 2nd grade children of different schools in Catalonia and its relation to reflex status using the INPP Test battery for use in schools.
The Test battery consists on:
Ayres Test for the Asymmetric Tonic Neck Reflex Hoff -Schilder Test for the The Asymmetric Tonic Neck Reflex Ayres Test for the Symmetric Tonic Neck Reflex Erect Test for the Tonic Labyrinth Reflex
The assessment is through a 5-point likert scale where 0 means no retention of primitive reflexes and no immaturity and 5 means 100% dysfunction.
Measured: At the begining and at the end of an academic year
Secondary outcomes (3)
Motor skills
To assess the neuromotor maturation pre and post application of the INPP school programme in 2nd grade children of different schools in Catalonia and its relation to motor skills
To assess the motor skills it will be used the Movement Battery Assesment for children (MABC Test) internationally used to detect developmental coordination disorders (DCD)
The test has three specific dimensions of the child motor skills:
Hand dexterity Catching and aiming Balance. The assessment is through a 5-point likert scale where 0 means no disfunction and and 5 means 100% dysfunction.
Measured: At the begining and at the end of an academic year
oculomotor functioning
To assess the neuromotor maturation pre and post application of the INPP school programme in 2nd grade children of different schools in Catalonia and its relation to oculomotor functioning
To assess the oculomotor functioning it will be used the Developmental Eye Movement Test (DEM).
It´s a battery that includes three subtests to assess vertical and horizontal eye movements.
The evaluation is through 3 variables to be calculated for each child: horizontal time, vertical time and the ratio between both.
These results related to a range of age are compared with the table of the average values (table from 7 to 7 years and 11 months with its categorisation).
Measured: At the begining and at the end of an academic year
risk of presenting dyslexia.
To assess the neuromotor maturation pre and post application of the INPP school programme in 2nd grade children of different schools in Catalonia and its relation to the measure of risk of presenting dyslexia.
The tool to assess the risk of dyslexia is the Spanish Test Battery called Diagnosis and Early Detection of Dyslexia (PROLEXIA) designed to cover two main purposes: early detection and differential diagnostic testing to assess the risk of dyslexia.
The categorisation of prolexia risk ranges from very low risk (0 points) to very high risk (more than 200 points), through low ( 35-55), moderate ( 55-75) and high ( 75-110).
Measured: At the begining and at the end of an academic year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start10 Jun 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Universitària del Bages
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Not Monegal, MSc, Principal investigator, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030310
- Sponsor's protocol ID
- UManresa_Move&Learn 2023
- Acronym
- Move&Learn
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McWhirter K, Steel A, Adams J. The association between learning disorders, motor function, and primitive reflexes in pre-school children: A systematic review. J Child Health Care. 2024 Jun;28(2):402-428. doi: 10.1177/13674935221114187. Epub 2022 Jul 13.
PubMed 35830652Pecuch A, Gieysztor E, Wolanska E, Telenga M, Paprocka-Borowicz M. Primitive Reflex Activity in Relation to Motor Skills in Healthy Preschool Children. Brain Sci. 2021 Jul 23;11(8):967. doi: 10.3390/brainsci11080967.
PubMed 34439585Gieysztor EZ, Choinska AM, Paprocka-Borowicz M. Persistence of primitive reflexes and associated motor problems in healthy preschool children. Arch Med Sci. 2018 Jan;14(1):167-173. doi: 10.5114/aoms.2016.60503. Epub 2016 Jun 13.
PubMed 29379547
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Application of a Motor Programme Throughout an Academic Year on the Neurological Maduration of a Sample of 2nd Grade Children of Primary Schools in Catalonia
- ClinicalTrials.gov ID
- NCT06030310
- Acronym / sponsor ID
- Move&Learn / UManresa_Move&Learn 2023
- Conditions
- Child Development
- Keywords
- Primitive reflex, Motor function, Oculomotor function, Risk of presenting dyslexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Universitària del BagesUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
The persistence of primitive reflexes in school-age children can affect neuromotor maturation. Some studies link the persistence of primitive reflexes with specific learning difficulties, low academic performance, neurodevelopmental disorders, and behavioral problems. There are studies that suggest introducing intervention programs to help integrate the activity of these reflexes. The objective of this study is to assess the effects of implementing a motor program on the neurologic maturation of second-grade children throughout an academic year in Catalonia.
A prospective experimental longitudinal and randomized pre-post study will be conducted with two groups: Non Intervention group and intervention group, known as the INPP Movement Program Group (with daily application of the motor program), lasting for one academic year (from September '23 to June '24). Currently, a feasibility study will be conducted at a school in Valls, with a sample of 50 children, and data will be collected at the beginning and end of the academic year. The study will analyze primitive reflexes, motor skills related to balance and coordination, oculo-motor skills, and the risk of presenting dyslexia. Once the feasibility study is completed, the same study with appropriate modifications will be carried out in different schools across Catalonia during the academic year 2024 - 2025 (yet to be determined).
Detailed description
Introduction: In a study conducted in Catalonia in 2020, it was found that 18,3% of school-age children between 5 and 17 years old had some neurodevelopmental disorder. There are studies that relate neurodevelopment to neuromotor immaturity and the presence of primitive reflexes. Others studies associate primitive reflexes with: attention deficit (ADD), attention deficit/hyperactivity disorder (ADHD), motor disorders and cognitive performance disorders.
Neuromotor immaturity, as defined by The Institute for Neuro-Physiological Psychology (INPP), involves the retention of a set of primitive reflexes beyond the first year of life and the absence and/or underdevelopment of postural reflexes beyond three years of age.
Primitive reflexes promote movement, and through movement, these reflexes gradually integrate. As a result, primitive reflexes are replaced by more mature postural reactions that are used throughout life. Properly developed postural reactions form the basis of good posture, balance, and coordination. However, in older age, some primitive reflexes may remain unintegrated. Regardless of a child's age, the presence of these reflexes indicates neuromotor immaturity.
Some studies describe primitive reflexes as one of the contributing factors to neurodevelopmental disorders, affecting the harmonious motor development of the child. Immature motor skills have been linked to learning difficulties such as reading and writing problems, difficulties in numerical skills, dyslexia, and behavioral problems. The presence of retained primitive reflexes is more common in children with neurodevelopmental disorders, and it acts as a barrier to learning.
There is evidence linking the presence of primitive reflexes to visual skills in children aged 6 to 14 years. Visual skills can influence reading and writing due to the connection between visual skills and hand-eye coordination. These visual skills, along with balance, coordination, and postural control, are essential for fixing the gaze and reading and writing fluently.
Studies have shown that by reducing the presence of primitive reflexes through motor activity, learning difficulties can also be reduced, leading to improved academic performance in students.
In 1996, INPP developed a school program intended to be applied collectively in classrooms with the aim of reducing neuromotor immaturity in students aged 7 and above. This school program designed by INPP consists of two parts: the INPP Test Battery for schools and the INPP motor exercise program. The INPP Test Battery for schools comprises a set of tests to evaluate the presence of unintegrated primitive reflexes and psychomotor skills (primarily related to aspects of balance and coordination). The INPP motor exercise program consists of a set of exercises designed to replicate the developmental movements of infants during early stages of neurodevelopment. This assessment and therapeutic tool can be used by various professionals, but it is specifically designed for teachers and other professionals involved in education and child development to identify and treat children displaying signs of neuromotor immaturity. This tool has not been validated in English, Spanish, or Catalan.
Some studies have applied motor programs to reduce the presence of primitive reflexes and have shown improvements in the maturation of primitive reflexes. These programs are proposed as possible ways to address neuromotor immaturity.
There is limited evidence on the relationship between motor function, primitive reflexes, and learning impairments. A review on these three aspects, published in 2022, recommends further research on the topic.
Hypothesis: Implementing the INPP school program in classrooms for second-grade students in Catalan schools will enable the assessment and integration of remaining primitive reflexes, leading to improvements in neuro-motor maturation, oculomotor skills, and a reduction in the incidence of risk of dyslexia.
Objectives: After completing Phase 1, which involved a viability test of selected evaluation tools (April 2023), the objective is to initiate Phase 2:
Phase 2: Prospective experimental longitudinal non-randomized study with two groups: Non Intervention group and intervention group, known as the INPP Movement Program Group (with daily application of the motor program). The study will be conducted in second-grade students at Claret School in Valls. Both groups will undergo the INPP school program assessment battery and specific tests to evaluate oculomotor skills and the risk of dyslexia at the beginning and end of the school year. The INPP Movement Program Group will perform the INPP motor program for 15 minutes daily throughout the academic year, while the Non Intervention Group will continue their regular school curriculum without the specific motor program but may receive it in the following academic year (2024-25) if significant benefits for students are demonstrated.
This school program only excludes those children who have difficulties in performing the exercises (e.g., due to a motor impairment) or those who cannot understand the instructions and thus cannot be evaluated with the pre-program motor assessments (e.g., newcomers who don't understand the language).
Phase 3: Prospective experimental longitudinal study in different schools in Catalonia, each with a significant sample size, to assess neuromotor maturation pre- and post-application of the INPP school program in relation to different variables: primitive reflexes, oculomotor skills, and the risk of dyslexia in children.
Ethical Aspects:
This project has undergone evaluation by an ethics committee, and a favorable opinion was obtained in November 2022.
The legal guardians of the study participants will be informed through an information sheet prior to their inclusion and through an informative meeting that will take place at the schools. These guardians will sign the informed consent sheet. As this study involves child participants, the informed consent will be signed by the legal guardian.
Due to the nature of the study and its methodological phases, it is not anticipated that there will be any health risks to the participants during its execution. Moreover, those who wish to do so can withdraw from the study at any time without any negative repercussions.
At the end of the study, schools and/or families that wish to do so will receive a summary of the obtained results and publications resulting from the study, upon request to the principal investigator.
In the next school year, the option of applying the school program will be offered to the control group that did not receive it during the study.
All data will be coded, meaning each participant will be assigned a code, and it will be impossible to identify participants with the given responses, ensuring confidentiality. At all times, the General Data Protection Regulation (EU) 2016/679, the Data Protection Act (GDPR), Organic Law 3/2018, December 5, on personal data protection and guarantee of digital rights, and Organic Law 1/1982, May 5, on the protection of the civil right to honor, personal and family privacy, and one's own image will be respected. Additionally, the guidelines of the Code of Ethics of the College of Physiotherapists and the Declaration of Helsinki on human rights in medical research will be followed.
The data will be stored by the principal investigator in the OneDrive of the Fundació Universitària del Bages Campus Manresa of the UVic-UCC, linked to the project. The coded database will only be accessible to the research team members who need to analyze the results through a personalized and temporary link to the OneDrive of the Fundació Universitària del Bages Campus Manresa of the Uvic-UCC or on the laptop safeguarded by the principal investigator.
No recordings will be made as they are not essential for the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INPP Movement Program Group | Experimental | Other: The developmental Exercise Programme of INPPThe INPP Movement Program Group will consist on a group of children aged between 7 and 9 years old enrolled in the second grade class of a catalan school that will participate in the school motor program provided by the Institute of Neuro-Physiology Psychology (INPP). This program consists of exercises that replicate the developmental movements of babies. Each day, a set of specific exercises will be performed, it will be practiced for 6 weeks and replaced by another set of exercises. They will be conducted for 15 minutes daily throughout the entire academic year. |
| Non Intervention Group | No intervention | –Children aged between 7 and 9 years old enrolled in the second grade at a catalan school. Students in the Non Intervention Group will continue with their regular academic school year without any additional intervention. If any student from the INPP Movement Program Group chooses not to participate in the study, they will join the class of the Non Intervention Group during the time when their peers are engaged in the school motor program. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children enrolled in the second grade of the selected schools
- Age between 7 and 9 years
Key exclusion criteria (3 listed)
- Children unable to perform the exercises due to physical and/or cognitive limitations
- Those unable to consistently attend the therapy sessions (with an absence rate of more than 80%) or have physical limitations
- Children who cannot understand the language and therefore cannot complete the questionnaires and tests to be conducted
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 |
|---|---|---|
| The developmental Exercise Programme of INPPThe INPP school motor program consists of a series of developmental movements based on the normal movements of a child in their first year of life. Exercises must be performed as slow as possible and must be repeated for at least six weeks. Once the children have performed a set of movements, a new set will be presented for practice in a more complex position. The exercises are done on the floor and aid in developing: Proper alignment of the head with the body, trunk stability. Balance and coordination. The ability to use both sides of the body and upper and lower parts independently. Muscle tone in prone and supine position. Hand-eye coordination and visual skills | Other | INPP Movement Program Group |
Primary outcome
Reflex status
Time frame: At the begining and at the end of an academic year
To assess the neuromotor maturation pre and post application of the INPP school programme in 2nd grade children of different schools in Catalonia and its relation to reflex status using the INPP Test battery for use in schools. The Test battery consists on: Ayres Test for the Asymmetric Tonic Neck Reflex Hoff -Schilder Test for the The Asymmetric Tonic Neck Reflex Ayres Test for the Symmetric Tonic Neck Reflex Erect Test for the Tonic Labyrinth Reflex The assessment is through a 5-point likert scale where 0 means no retention of primitive reflexes and no immaturity and 5 means 100% dysfunction.
3 secondary outcomes
Motor skills
Time frame: At the begining and at the end of an academic year
oculomotor functioning
Time frame: At the begining and at the end of an academic year
risk of presenting dyslexia.
Time frame: At the begining and at the end of an academic year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 35830652McWhirter K, Steel A, Adams J. The association between learning disorders, motor function, and primitive reflexes in pre-school children: A systematic review. J Child Health Care. 2024 Jun;28(2):402-428. doi: 10.1177/13674935221114187. Epub 2022 Jul 13.
- Background: PubMed 34439585Pecuch A, Gieysztor E, Wolanska E, Telenga M, Paprocka-Borowicz M. Primitive Reflex Activity in Relation to Motor Skills in Healthy Preschool Children. Brain Sci. 2021 Jul 23;11(8):967. doi: 10.3390/brainsci11080967.
- Background: PubMed 29379547Gieysztor EZ, Choinska AM, Paprocka-Borowicz M. Persistence of primitive reflexes and associated motor problems in healthy preschool children. Arch Med Sci. 2018 Jan;14(1):167-173. doi: 10.5114/aoms.2016.60503. Epub 2016 Jun 13.
- The association between learning disorders, motor function, and primitive reflexes in pre-school children: A systematic review.Link provided by the sponsor.
- Primitive Reflex Activity in Relation to Motor Skills in Healthy Preschool ChildrenLink provided by the sponsor.
- Persistence of primitive reflexes and associated motor problems in healthy preschool children.Link provided by the sponsor.
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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.
Marta Not Monegal, MSc principal investigator
University of Vic - Central University of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The developmental Exercise Programme of INPP in people with Child Development, run by Fundació Universitària del Bages at 1 site in Spain.
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 3 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 11 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Not Monegal, MSc (0034656366323, mnot@umanresa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflex status (time frame: At the begining and at the end of an academic year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030310, which also lists 3 linked publications.
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 11 Sep 2023.