Infant DevelopmentNCT05264064
The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation
An observational study of Infant Development, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- The motor assessment to establish validation of the Polish version of the AIMS
- How many people
- 145 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- a gestational age between 37 and 42 weeks
- birth weight of ≥ 2500 g
- five-minute Apgar score ≥ 8.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Medical Sciences
Poznan, Wielkopolska, 61-701
About this study
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.
Read the 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.
- Conditions
- Infant Development
- Being tested
- The motor assessment to establish validation of the Polish version of the AIMS
- Keywords
- Infant Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The motor assessment to establish validation of the Polish version of the AIMSOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: The motor assessment to establish validation of the Polish version of the AIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
The study of the concurrent validity of the Polish version of the AIMS
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start20 Nov 2020
- Primary completion25 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Małgorzata Eliks, Poznan University of Medical Sciences
- Investigators
- Małgorzata Eliks, Msc, Study director, Poznan University of Medical Sciences, Department of Developmental Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264064
- Sponsor's protocol ID
- 1034/19
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27699768Piper 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.
PubMed 1468050Saccani 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.
PubMed 27636655Fleuren 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.
PubMed 17407470Wang 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.
PubMed 30009165Morales-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.
PubMed 28125359Aimsamrarn 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.
PubMed 30703619Eliks 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.
PubMed 37173690Eliks 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.
PubMed 35968314
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Polish Version of the Alberta Infant Motor Scale: Cultural Adaptation and Validation
- ClinicalTrials.gov ID
- NCT05264064
- Acronym / sponsor ID
- 1034/19
- Conditions
- Infant Development
- Keywords
- Infant Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants aged 0-18 months | – | Other: The motor assessment to establish validation of the Polish version of the AIMSHealthy infants aged 0-18 months, divided into four age groups: 0-3 months, 4-7 months, 8-11 months, and older than 12 months |
Who may qualify
- Ages
- 2 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- a gestational age between 37 and 42 weeks
- birth weight of ≥ 2500 g
- five-minute Apgar score ≥ 8.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The motor assessment to establish validation of the Polish version of the AIMSThe 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). | Other | Infants aged 0-18 months |
Primary outcome
The reliability of the Polish version of the AIMS
Time frame: 4 months
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.
1 secondary outcome
The study of the concurrent validity of the Polish version of the AIMS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Results publication: PubMed 27699768Mendonca 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.
- Results publication: PubMed 1468050Piper 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.
- Results publication: PubMed 27636655Saccani 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.
- Results publication: PubMed 17407470Fleuren 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.
- Results publication: PubMed 30009165Wang 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.
- Results publication: PubMed 28125359Morales-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.
- Results publication: PubMed 30703619Aimsamrarn 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.
- Derived from this study: PubMed 37173690Eliks 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.
- Derived from this study: PubMed 35968314Eliks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Eliks, Msc study director
Poznan University of Medical Sciences, Department of Developmental Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reliability of the Polish version of the AIMS (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05264064, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.