Skip to main content
OpenTrials
Completed

NCT Number: NCT07254780

Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm

INTRODUCTION: This project is presented as a continuation of the one approved in 2019 (Code: UALBIO2019/013). Early Intervention is defined as all interventions, including prevention, carried out with children aged 0-6 years, their families, and their environment, in order to respond to what each child needs to advance in their development as early as possible.

Psychomotor Delay indicates a slow developmental trajectory in several areas. Premature infants frequently face a potential psychomotor delay, usually due to the immaturity associated with being born earlier than expected. Children born preterm account for 50% of functional diversity in the pediatric population, presenting sequelae in the perinatal period, in the short term, and in the long term. In a previous study conducted by our group, the importance of early follow-up and treatment for children born very preterm was demonstrated.

Neurodevelopmental disorders with motor impairments in children require physiotherapy treatment from the time of diagnosis, throughout early childhood intervention, and across the lifespan. The most prevalent condition is cerebral palsy, which is the leading cause of childhood disability. Its prevalence ranges from 1.5 to 3.0 per 1,000 live births, with no major changes observed in adolescent and adult populations, and with higher occurrence in males than females. Other important conditions due to their frequency and symptoms include congenital malformations and syndromes.

OBJECTIVE: To analyze the effects of advanced physiotherapy programs on development, activity, and participation in children receiving early intervention and presenting motor disorders.

METHODOLOGY: Clinical trial with experimental groups and one control group. Advanced physiotherapy programs based on evidence will be studied, carried out with and involving the family, and supported by specialized care.

The sample will be obtained from centers and associations collaborating with the University of Almería. Before conducting the study, informed consent will be requested from parents or legal guardians. Baseline assessments and follow-up measurements will be performed. Validated and relevant variables related to development and motor difficulties will be used. The data obtained during the project will be stored in a database.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Baby 26 to 32 Weeks Female Urogenital Diseases and Pregnancy Complications Mental Disorders Motor Disorder Motor Disorders Neurodevelopment Neurodevelopment Treatment Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Babies Premature Birth Urogenital Diseases

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Almería

Almería, 04120, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature infants with a gestational age between 24 and 32 weeks, with an adequate weight for their gestational age

Exclusion criteria

  • Neurological disorders
  • Invasive mechanical ventilation
  • Congenital disorders
  • Necrotising enterocolitis
  • Metabolic diseases
  • Intraventricular hemorrhage grade 3-4
  • Genetic disorders
  • Oral disorders that make this process difficult(cleft palate, cleft lip...)
  • Serious illnesses according to medical criteria

Treatment and study plan

Bobath

Other

This group will receive an intervention based on the Bobath Concept, following the Bobath Clinical Reasoning Framework (BCRF). This approach adopts a holistic, systems-science perspective, considering the dynamic interaction between body functions, activities, participation, and contextual factors according to the ICF model.

Early Intervention

Other

This group will receive standard pediatric physiotherapy commonly implemented in early intervention services for children with motor disorders. The treatment will follow conventional approaches with a more impairment-based focus

Ordinary care

Other

This group will receive ordinary care, defined as the standard protocol-based follow-up provided by the public health system, unrelated to Early Intervention physiotherapy services

Primary outcomes

  1. Gross Motor Skills

    Time frame: 2 Years

    To evaluate the baby's gross motor competence during early motor development, the investigators will employ the Alberta Infant Motor Scale (AIMS). This tool, developed by Canadian researchers, is an observational assessment designed for infants from birth until they achieve independent walking. It includes 58 items that examine antigravity muscle control and overall motor performance across four positions: prone, supine, sitting, and standing (de Albuquerque et al., 2015).

    This tool provides percentile scores (0-100) for gross motor developmental, with higher scores indicating more advanced abilities.

  2. Neuromotor Development

    Time frame: 2 Years

    To evaluate motor, cognitive, and language development, the investigators will use the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), one of the most widely applied instruments for assessing early development. Its primary purpose is to identify children who may present developmental delays and to guide the planning of appropriate interventions. The Bayley-III consists of six subscales that measure cognitive, language, motor, social-emotional, adaptive, and behavioral skills in children aged 1 to 42 months (de Albuquerque et al., 2018).

    This tool provides percentile scores (0-100) for each developmental domain, with higher scores indicating more advanced abilities.

Secondary outcomes

  1. Parents Experiences about Development

    Time frame: 2 Years

    To screen overall developmental progress, the investigators will use the Ages & Stages Questionnaires, Third Edition (ASQ-3). This parent-completed tool assesses children from 1 to 66 months across five domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Each questionnaire includes age-specific items that allow caregivers to report their child's abilities through simple observations.

    The ASQ-3 helps identify children who may need monitoring or further evaluation, providing a practical and reliable measure of early developmental functioning.

    This tool provides scores (0-60) for each developmental domain, with higher scores indicating more advanced abilities.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.