Clinical trial NCT05264064: The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation
Official title: The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: Infant Development
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 145
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 145 healthy infants aged 0-18 months, divided into four age groups: 0-3 months, 4-7 months, 8-11 months, and older than 12 months

Brief summary: The aim of the study was to derive a Polish version of the AIMS through its cultural adaptation and validation. This process was based on an analysis of intra- and interrater reliability, as well as concurrent validity, using PDMS-2.

Detailed description: The monitoring infant motor development allows for detecting delays and disturbances, enabling, if necessary, early therapeutic interventions to prevent further structural and functional disorders. However, the developmental assessment should be performed using standardised tools, which need to undergo cultural adaptation adapted and validation. This process is necessary to ensure their reliability in countries, cultures, populations, and languages different than initially intended.

The Alberta Infant Motor Scale (AIMS) is a diagnostic tool for the developmental evaluation of infants from the time of birth, to the period of independent walking (0-18 months), based on the observation of spontaneous motor performance \[9,10\]. It is based on several assumptions of the neuromaturational model and the concepts of the dynamic systems development theory. The AIMS was created in the early 1990s by Piper and Darrah, validated and standardised on the Canadian population \[9,10\]. Moreover, a 2014 re-evaluation of the scale noted that the normative values in this population remained stable.

The intended uses of the AIMS comprise: 1) identification of infants with motor delay, 2) providing medical professionals and parents information on motor achievements of the infant (both currently developing activities and those not observed in the infant's repertoire), 3) measurement of motor performance over time, or before and after an intervention, 4) as a research tool for the estimation of rehabilitation program efficacy in infants with motor delays .

The scale has been used (as an outcome measure) in numerous studies in healthy infants and those affected by or at risk of developmental disorders.

So far, research on the reliability and validity of the AIMS has been performed in Japanese, Chinese, Brazilian, Spanish, Thai, Greek, Dutch, Flemish and Serbian sample groups. However, there has not yet been a study conducted in any Middle European population.

The aim of the study was to derive a Polish version of the AIMS through its cultural adaptation and validation. This process was based on an analysis of the intra- and interrater reliability, as well as concurrent validity, using PDMS-2.

Eligibility criteria: Inclusion Criteria:

* a gestational age between 37 and 42 weeks
* birth weight of ≥ 2500 g
* five-minute Apgar score ≥ 8.

Exclusion Criteria:

* a gestational age \< 37 weeks,
* a birth weight \< 2500 g,
* five-minute Apgar score \< 8
* the presence of any neurological, orthopedic, genetic, metabolic, and sensory disorders.

Primary outcomes:
measure: The reliability of the Polish version of the AIMS
timeFrame: 4 months
Secondary outcomes:
measure: The study of the concurrent validity of the Polish version of the AIMS
timeFrame: 12 months
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences, Department of Developmental Neurology
name: Małgorzata Eliks, Msc
role: STUDY_DIRECTOR
References:
citation: Mendonca B, Sargent B, Fetters L. Cross-cultural validity of standardized motor development screening and assessment tools: a systematic review. Dev Med Child Neurol. 2016 Dec;58(12):1213-1222. doi: 10.1111/dmcn.13263. Epub 2016 Oct 4.
citation: Piper MC, Pinnell LE, Darrah J, Maguire T, Byrne PJ. Construction and validation of the Alberta Infant Motor Scale (AIMS). Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S46-50.
citation: Saccani R, Valentini NC, Pereira KR. New Brazilian developmental curves and reference values for the Alberta infant motor scale. Infant Behav Dev. 2016 Nov;45(Pt A):38-46. doi: 10.1016/j.infbeh.2016.09.002. Epub 2016 Sep 13.
citation: Fleuren KM, Smit LS, Stijnen T, Hartman A. New reference values for the Alberta Infant Motor Scale need to be established. Acta Paediatr. 2007 Mar;96(3):424-7. doi: 10.1111/j.1651-2227.2007.00111.x.
citation: Wang H, Li H, Wang J, Jin H. Reliability and Concurrent Validity of a Chinese Version of the Alberta Infant Motor Scale Administered to High-Risk Infants in China. Biomed Res Int. 2018 Jun 13;2018:2197163. doi: 10.1155/2018/2197163. eCollection 2018.
citation: Morales-Monforte E, Bagur-Calafat C, Suc-Lerin N, Fornaguera-Marti M, Cazorla-Sanchez E, Girabent-Farres M. The Spanish version of the Alberta Infant Motor Scale: Validity and reliability analysis. Dev Neurorehabil. 2017 Feb;20(2):76-82. doi: 10.3109/17518423.2015.1066461. Epub 2015 Aug 18.
citation: Aimsamrarn P, Janyachareon T, Rattanathanthong K, Emasithi A, Siritaratiwat W. Cultural translation and adaptation of the Alberta Infant Motor Scale Thai version. Early Hum Dev. 2019 Mar;130:65-70. doi: 10.1016/j.earlhumdev.2019.01.018. Epub 2019 Jan 28.
citation: Eliks M, Sowinska A, Gajewska E. The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation. Front Neurol. 2022 Jul 28;13:949720. doi: 10.3389/fneur.2022.949720. eCollection 2022.