Effects of Application of a Motor Programme on Neurological Maduration in Children

NCT06030310 | Recruiting DMC

• 1 other identifier: UManresa_Move&Learn 2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Child Development

Keywords

Primitive reflex; Motor function; Oculomotor function; Risk of presenting dyslexia

Outcome Measures

Primary Outcomes (1)

• 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.

  At the begining and at the end of an academic year

Secondary Outcomes (3)

• Motor skills

  At the begining and at the end of an academic year

• oculomotor functioning

  At the begining and at the end of an academic year

• risk of presenting dyslexia.

  At the begining and at the end of an academic year

Study Arms (2)

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.

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.

Interventions

The developmental Exercise Programme of INPP OTHER

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

INPP Movement Program Group

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children enrolled in the second grade of the selected schools
• Age between 7 and 9 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Universitària del Bages: lead

Study Sites (1)

Marta Not Monegal

Manresa, Barcelona, 08243, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 35830652 BACKGROUND

• Pecuch 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.

  PMID: 34439585 BACKGROUND

• Gieysztor 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.

  PMID: 29379547 BACKGROUND

Related Links

• The association between learning disorders, motor function, and primitive reflexes in pre-school children: A systematic review.
• Primitive Reflex Activity in Relation to Motor Skills in Healthy Preschool Children
• Persistence of primitive reflexes and associated motor problems in healthy preschool children.

Study Officials

• Marta Not Monegal, MSc

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Not Monegal, MSc

CONTACT

0034656366323; mnot@umanresa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 11, 2023
• Study Start: June 10, 2023
• Primary Completion: June 20, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

ES (1)