NCT06180330

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

May 9, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 12, 2023

Last Update Submit

May 8, 2024

Conditions

Keywords

swimmingmotor developmentinfant

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Aquatic baby class

EXPERIMENTAL

8 weeks program of aquatic exercises for infants

Other: Aquatic baby class

No intervention

NO INTERVENTION

No intervention

Interventions

The intervention will consist of exercises for infants. They will be in the water together with parents

Aquatic baby class

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants age 3-12 months

You may not qualify if:

  • any disability that would affect motor development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jozef Pilsudski University of Physical Education in Warsaw

Warsaw, 00-968, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

December 15, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

May 9, 2024

Record last verified: 2023-12

Locations