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NCT Number: NCT07353112

Validation of the French Translation of the SOSI-M

The aim of this study is to validate the French version of the SOSI-M test on healthy children as well as on children with neurodevelopmental disorders (NDDs).

Therefore, the investigators will conduct a video recording of the test administration on a group of healthy children and on a group of children with NDDs.

The research question is: Is the French translation of the SOSI-M test equivalent, in terms of functionality and expected results, to the original version for a population of healthy children and children with mild to moderate neurodevelopmental disorders?

The hypothesis is that the psychometric properties of the French version are similar to those of the original version.

Secondly, the investigators will investigate: Does the difference in socio-cultural context between healthy Belgian and Senegalese children influence the SOSI-M score?

The hypothesis is that healthy Belgian children obtain better scores compared to healthy Senegalese children.

The scores of the two groups will be compared with each other and with those obtained in previous studies. Intra- and inter-rater reliability will also be assessed.

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Key information

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For the groupe of children with neurodevelopmental disorders :

Inclusion criteria

  • neurodevelopmental disorder (NDD)
  • speak french and understand instructions in French
  • and have not been assessed with the SOSI-M in the past 6 months.

Exclusion criteria

  • Severe motor/cognitive impairment
  • uncorrected visual/auditory impairment
  • cerebral palsy diagnosis

For the neurotypical children :

Inclusion criteria

  • speak french and understand french instructions

Exclusion criteria

  • diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
  • health condition that contraindicates taking the SOSI-M

Treatment and study plan

Administration of the French translation of the SOSI-M test.

Diagnostic Test

Filmed administration of the French translation of the SOSI-M test

We will then compare the scores of the two groups between them and with the scores obtained by other studies.

There will be two operators that will evaluate each video 2 times (3 weeks between each evaluation) in order to mesure the metrologics qualities like fidelity.

Primary outcomes

  1. SOSI-M score

    Time frame: 1 day for the filmed passation of the french version of the sosi-m test.

    For the total raw score :

    0 = Abnormal 64 = Normal development of the child

Sponsors and collaborators

Lead sponsor

Haute Ecole Ilya Prigogine

Other

Registry information

Official study title

Validation of the French Translation of SOSI-M in Healthy Children and in Children With Mild to Moderate Neurodevelopmental Disorder

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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