Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

NCT04693494 | Completed

• 1 other identifier: ufernandez2020
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

Conditions

Term; Healthy; Motor Delay; Development, Infant

Keywords

motor milestones; term; newborn; motor development

Outcome Measures

Primary Outcomes (3)

• Score of the Alberta Infant Motor Scale (AIMS) at month 9

  AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.

  9 months old

• Score of the Alberta Infant Motor Scale (AIMS) at month 12

  AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.

  12 months old

• Score of the Alberta Infant Motor Scale (AIMS) at month 15

  AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.

  15 months old

Study Arms (2)

Intervention group

EXPERIMENTAL

Four training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given advices. Three evaluations of motor milestones at the age of 9, 12, and 15 months old

Other: Training program

Control group

NO INTERVENTION

Three evaluations of motor milestones at the age of 9, 12, and 15 months old

Interventions

Training program OTHER

Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.

Intervention group

Eligibility Criteria

• Age: 1 Day - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy-term infants
• Male and female
• Apgar score of at least 7 in the first minute and at five minutes.
• Natural or cesarean birth
• Absence of congenital malformations or orthopedic injury
• Absence of known congenital or genetic pathology
• Normal neurological medical examination of the newborn at hospital discharge.

You may not qualify if:

• Newborns who have required hospitalization before being enrolled.
• Multiple births

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Universidad San Jorge

Zaragoza, Aragon, 50019, Spain

Location

Related Publications (1)

• Fernandez-Sola L, Cano-Diez B, Pons-Solaz Y, Vera-Egido B, Moreno-Gonzalez S. Effectiveness of a training program for the acquisition of motor milestones in infants: a randomized clinical trial. Ital J Pediatr. 2025 Jan 31;51(1):23. doi: 10.1186/s13052-025-01849-4.

  PMID: 39891196 DERIVED

MeSH Terms

Conditions

Psychomotor Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Fernández Sola, Physical Th

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

• Beatriz Cano Díez, Physical Th

  Universidad San Pablo CEU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded: spontaneous behavior of babies is evaluated, that doesn't depend of having knowledge of the intervention. Outcomes assessor doesn't know the evaluated baby group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: Intervention and control group.

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: December 1, 2019
• Primary Completion: December 7, 2020
• Study Completion: January 17, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years
• Access Criteria: Información will be shared with editors or other investigators

Locations

ES (1)