- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05264064
The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Wielkopolska
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Poznań, Wielkopolska, Poland, 61-701
- Poznan University of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Infants aged 0-18 months
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
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The translation, cultural adaptation, and validation were conducted according to existing recommendations.
The motor development of infants was assessed with the Polish scoresheet of the AlMS and the PDMS v.2.
The examination was conducted by two peadiatric physiotherapists with a minimum 7 years of experience.The examination methodology was concordant with the recommendation of the authors of AIMS and PDMS-2.The intrarater reliability test included two assessments (with one-month interval) performed by one researcher (Rater A).
For the second assessment, the videos of spontaneous motor performance of infants were recorded during the examination.
The interrater reliability involved assessments by two researchers (Rater A, Rater B).
The Gross Motor Scales of the PDMS v.2 was administered to estimate concurrent validity (participants at the age of 0-12 months).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The reliability of the Polish version of the AIMS
Time Frame: 4 months
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The intrarater reliability test included two assessments (with one-month interval) of every participants with the Polish version AIMS performed by one researcher - a peadiatric physiotherapist (Rater A). For the second assessment, the videos of spontaneous motor performance of infants were recorded during the examination. The interrater reliability involved assessments of every participants by the Polish version of AIMS by two researchers - peadiatric physiotherapists (Rater A, Rater B). Intrarater and interrater reliability were examined via calculation of the intraclass correlation coefficient (ICC) and the 95% confidence interval (95%CI) of the ICC for the subscales, as well as total scores for the four studied age groups. |
4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The study of the concurrent validity of the Polish version of the AIMS
Time Frame: 12 months
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The concurrent validity was examined by the comparison the AIMS and the Gross Motor Scales of the Peabody Developmental Motor Scales v.2, which were administered to participants at the age of 0-12 months. Correlations between gross motor scales of PDMS-2 and AIMS were evaluated using the Spearman rank coefficient. |
12 months
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Collaborators and Investigators
Investigators
- Study Director: Małgorzata Eliks, Msc, Poznan University of Medical Sciences, Department of Developmental Neurology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Front Neurol. 2023 Jan 18;14:1136965.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1034/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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