The Impact of Water Activities on Motor Development in Infants

Infant Development Clinical Trial

Official title:

The Impact of Water Activities on Motor Development in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06180330
• Other study ID #: 01-47/2023
• Status: Completed
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: December 2023
• Source: Józef Pilsudski University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted at various city swimming pools in Warsaw. The study participants will include 20 infants participating in aquatic baby classes once a week and 20 infants not participating in any classes and their parents. The study will be conducted in a quiet and calm room, which will be prepared in advance and equipped with a smooth mat, a lounger and infant toys. The estimated time to conduct the study is about 30 minutes.

The examination will be carried out twice: before the start of the two-month course and after its completion. Each time in the presence of a parent or legal guardian, after signing a consent form for the study.

The selected methods of assessing motor development are fully non-invasive and consist of the following tests:

1. Alberta Infant Motor Scale (AIMS)-a test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills.

2. Early Motor Development Questionnaire (EMQ)-will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

Inclusion Criteria:

• infants age 3-12 months

Exclusion Criteria:

• any disability that would affect motor development

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• Aquatic baby class
The intervention will consist of exercises for infants. They will be in the water together with parents

Locations

Country	Name	City	State
Poland	Jozef Pilsudski University of Physical Education in Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Alberta Infant Motor Scale (AIMS) at 8 weeks	The test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills.; During the assessment, the evaluator observes the movements of the child and scores each movement component as either "observed" or "not observed".	Baseline and 8 weeks
Primary	Change from Baseline in the Early Motor Development Questionnaire (EMQ) at 8 weeks	The questionnaire will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.; EMQ incorporates parents' certainty in their answers by using a 5-point scale ranging from -2 (the parent is sure the child does not show the behavior yet) to +2 (the parent remembers a particular instance in which the child exhibited the behavior).	Baseline and 8 weeks