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

NCT07254780 | Completed

• 1 other identifier: BOBprem
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Baby 26 to 32 Weeks; Premature Babies; Neurodevelopment; Neurodevelopment Treatment; Motor Disorder

Keywords

Physical Stimulation; Premature infant; Neurodevelopment; Neurodevelopment Treatment

Outcome Measures

Primary Outcomes (2)

• Gross Motor Skills

  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 Years

• Neuromotor Development

  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.

  2 Years

Secondary Outcomes (1)

• Parents Experiences about Development

  2 Years

Study Arms (3)

TreatBOB

EXPERIMENTAL

Other: Bobath

TreatNO-BOB

EXPERIMENTAL

Other: Early Intervention

NoTreat-NO-BOB

EXPERIMENTAL

Other: Ordinary care

Interventions

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.

TreatBOB

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

TreatNO-BOB

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

NoTreat-NO-BOB

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University of Almería

Almería, 04120, Spain

Location

Related Publications (5)

• Bernabe-Zuniga JE, Rodriguez-Lucenilla MI, Alias-Castillo AJ, Rueda-Ruzafa L, Roman P, Del Mar Sanchez-Joya M. Early interventions with parental participation and their implications on the neurodevelopment of premature children: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2025 Mar;34(3):853-865. doi: 10.1007/s00787-024-02528-1. Epub 2024 Jul 19.

  PMID: 39028424 BACKGROUND

• Alonso-Fernandez S, de Liria CRG, Lluch-Canut T, Poch-Pla L, Perapoch-Lopez J, Juve-Udina ME, Martinez-Momblan MA, Hurtado-Pardos B, Roldan-Merino JF. Psychometric properties of the oral feeding assessment in premature infants scale. Sci Rep. 2022 May 12;12(1):7836. doi: 10.1038/s41598-022-11521-0.

  PMID: 35551222 BACKGROUND

• de Albuquerque PL, Lemos A, Guerra MQ, Eickmann SH. Accuracy of the Alberta Infant Motor Scale (AIMS) to detect developmental delay of gross motor skills in preterm infants: a systematic review. Dev Neurorehabil. 2015 Feb;18(1):15-21. doi: 10.3109/17518423.2014.955213. Epub 2014 Oct 3.

  PMID: 25279804 BACKGROUND

• Albuquerque PL, Guerra MQF, Lima MC, Eickmann SH. Concurrent validity of the Alberta Infant Motor Scale to detect delayed gross motor development in preterm infants: A comparative study with the Bayley III. Dev Neurorehabil. 2018 Aug;21(6):408-414. doi: 10.1080/17518423.2017.1323974. Epub 2017 May 24.

  PMID: 28537470 BACKGROUND

• Seesahai J, Luther M, Church PT, Maddalena P, Asztalos E, Rotter T, Banihani R. The assessment of general movements in term and late-preterm infants diagnosed with neonatal encephalopathy, as a predictive tool of cerebral palsy by 2 years of age-a scoping review. Syst Rev. 2021 Aug 12;10(1):226. doi: 10.1186/s13643-021-01765-8.

  PMID: 34384482 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Motor Disorders

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Doctor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: July 22, 2023
• Primary Completion: July 22, 2025
• Study Completion: September 22, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available for one year once the study is finished
• Access Criteria: Reasonable request to reproduce the intervention performed on this study

Locations

ES (1)