Clinical trial NCT06608576: Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays
Official title: Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: High-risk Infants
Keywords: early intervention
telerehabilitation
physical therapy
child development
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Universitario San Cecilio de Granada
First posted: 2024-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline and Month 2.
measure: Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.
timeFrame: Baseline and Month 2.
measure: Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.
timeFrame: Baseline and Month 2.
Secondary outcomes:
measure: Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2.
timeFrame: Baseline and Month 2.
measure: Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2.
timeFrame: Baseline and Month 2.
measure: Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Month 2
measure: Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2.
timeFrame: Baseline and Month 2.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio de Granada
Study officials:
References: