Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

NCT06608576 | Enrolling By Invitation

• 1 other identifier: BBL-ATPO-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.

Conditions

High-risk Infants

Keywords

early intervention; telerehabilitation; physical therapy; child development

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.

  The BSID-III is an assessment tool for diagnosing developmental delays in early childhood from 1 to 42 months. It assesses 5 developmental domains: Cognitive Scale, Language Scale, Motor scale, Social-Emotional Scale and Adaptative Scale. The motor scale has 66 items in the fine motor and 72 items in the gross motor domain which are administrated according to the child development. Change= (2 months development score - baseline Score).

  Baseline and Month 2.

• Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.

  The AIMS is an observational assessment tool that requires minimal handling of an infant by the examiner. It assesses the maturation of infant's motor skills from term (40 weeks gestation) to 18 months. It has 58 observational items divided into four subscales which are prone, supine, sitting and standing. Change= (2 months development score - baseline Score).

  Baseline and Month 2.

• Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.

  The IMP is a video-based assessment for infants aged 3 to 18 months. It assesses the spontaneous motor behaviour in supine, prone, sitting, standing, walking and during reaching and grasping - depending on the age of the infant. Includes 5 domains: the size of the infant's motor repertoire, the infant's ability to make an adaptive selection out of his/her repertoire, performance, symmetry and fluency. Change= (2 months IMP total and subscales scores - baseline scores).

  Baseline and Month 2.

Secondary Outcomes (4)

• Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2.

  Baseline and Month 2.

• Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2.

  Baseline and Month 2.

• Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).

  Month 2

• Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2.

  Baseline and Month 2.

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

participants will receive face-to-face early intervention treatment on physical therapy area once a month for two months.

Other: Face-to-face standard treatment

Telematic Support

EXPERIMENTAL

Participants will receive weekly telematic early intervention sessions at home via video conferencing for two months.

Other: Telematic Support

Interventions

Face-to-face standard treatment OTHER

Individualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session.

Standard Treatment

Telematic Support OTHER

The physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary.

Telematic Support

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
• At risk of neurodevelopmental delays or disorders.
• Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.

You may not qualify if:

• Independent walking children.
• Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
• Infants with orthoses and/or prostheses.
• Children with health complications that enable the child's participation in the study.
• Not spanish-speaking parents.

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital Universitario San Cecilio de Granada: collaborator

Study Sites (1)

Hospital Universitario San Cecilio de Granada

Granada, Granada, 18007, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Professor at University of Granada

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: February 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

ES (1)