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CompletedNCT04693494Updated May 16, 2024

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

An interventional study of Training program in Term, Healthy and Motor Delay, sponsored by Universidad San Jorge. Completed at 1 site in Spain. Open to participants aged 1 Day to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Universidad San Jorge · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
1 Day to 9 Months
Sex
All
01

Study 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.

Read the detailed description

Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.

Intervention group:

  1. 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 bits of advice.
  2. Three evaluations of motor milestones at 9, 12, and 15 months old.

Control group:

  1. Three evaluations of motor milestones at 9, 12, and 15 months old.
02

Conditions studied

  • Term
  • Healthy
  • Motor Delay
  • Development, Infant

Keywords

  • motor milestones
  • term
  • newborn
  • motor development
03

Who can participate

Ages eligible
1 Day to 9 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Newborns who have required hospitalization before being enrolled.
  • Multiple births
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Intervention group

    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

  • No intervention
    Control group

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

Interventions

  • OtherTraining program

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months old

  2. 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.

    Time frame: 12 months old

  3. 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.

    Time frame: 15 months old

06

Study locations

1 site
  • Universidad San Jorge
    Zaragoza, Aragón 50019, Spain
07

References and documents

Individual participant data

Plan to share: Yes — All collected IPD after deidentified

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04693494
Lead sponsor
Universidad San Jorge
Responsible party
Luis Fernandez (Physical Therapist, Universidad San Jorge) — Principal investigator
First posted
Jan 5, 2021
Start date
Dec 1, 2019
Primary completion
Dec 7, 2020
Completion
Jan 17, 2023
Last update
May 16, 2024

Study contacts

Luis Fernández Sola, Physical Th
principal investigator · Universidad San Jorge
Beatriz Cano Díez, Physical Th
study director · Universidad San Pablo CEU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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