Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Face-to-face standard treatment, Telematic Support.
- Who it may be relevant to
- Registry conditions: High-risk Infants. Basic parameters: 3 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders
Overview
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.
Interventions
- Other Face-to-face standard treatment
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. - Other Telematic Support
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.
Primary outcome measures
- 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. [Time frame: Baseline and Month 2.]
- Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2. [Time frame: Baseline and Month 2.]
- Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2. [Time frame: Baseline and Month 2.]
Secondary outcome measures (4)
- Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2. [Time frame: Baseline and Month 2.]
- Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2. [Time frame: Baseline and Month 2.]
- Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8). [Time frame: 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. [Time frame: Baseline and Month 2.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Universitario San Cecilio de Granada — Granada
Identifiers
NCT: NCT06608576 · BBL-ATPO-2023