NCT05264064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 10, 2022

Last Update Submit

February 21, 2022

Conditions

Keywords

Infant Development

Outcome Measures

Primary Outcomes (1)

  • The reliability of the Polish version of the AIMS

    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

Secondary Outcomes (1)

  • The study of the concurrent validity of the Polish version of the AIMS

    12 months

Study Arms (1)

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

Other: The motor assessment to establish validation of the Polish version of the AIMS

Interventions

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).

Infants aged 0-18 months

Eligibility Criteria

Age2 Weeks - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

Related Publications (9)

  • 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, Anna S, Barbara S, Gajewska E. The standardization of the Polish version of the Alberta Infant Motor Scale. BMC Pediatr. 2023 May 12;23(1):236. doi: 10.1186/s12887-023-04055-5.

  • 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.

Study Officials

  • Małgorzata Eliks, Msc

    Poznan University of Medical Sciences, Department of Developmental Neurology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD student, Director of the project

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 3, 2022

Study Start

November 20, 2020

Primary Completion

September 25, 2021

Study Completion

September 30, 2021

Last Updated

March 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations