Clinical trial NCT05319158: The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
Official title: The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Risk
Early Intervention
Keywords: neonatal therapy
general movements
high risk neurodevelopment
physiotherapy
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
name: Hospital Parc Taulí (Sabadell, Barcelona)
First posted: 2022-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The infants will be pre-stratified according to General Movement Optimality Score (GMOs). The Control group will receive standard care and the Intervention groups will begin the therapy at 34-36w. The intervention will be explained and guided by the principal researcher and experienced Pediatric Physical therapist. Parents will conduct the intervention until the 50-52 weeks PMA. General Movement Assessment (GMA) will be performed at term, 44w and 54w PMA.

Motor assessment will be carried out at 6 months Corrected Age (CA) and a global assessment at 12 months CA.

Those assessments will be performed by independent and blind professionals at their corresponding Hospitals.
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period. We will describe the short and long-term differences between infants exposed to MIT-PB and infants who follow current standard care.

Detailed description: The quasi-experimental design has been planned to assess the effect of a physiotherapy program carried out in neonatal intensive care and at home during the first months of life. Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included.

Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA), 54 weeks PMA, 6 months, and 12 months.

A qualitative study has been designed to assess the physiotherapy performance and parents' experience.

Three different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention groups (n=18) will be located at Hospital Josep Trueta of Girona and Hospital Sant Joan de Déu and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).

Eligibility criteria: Inclusion Criteria:

* Preterm infants born before 32w GA and less than 1500g weight.
* Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual age (PMA).
* Families able to understand/speak Catalan, Spanish or English.
* Families willing to participate who have the informed consent

Exclusion Criteria:

* Infants with congenital abnormalities and/or genetic disorders
* Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36 weeks PMA.
* Infants with Normal General Movements at 34-36 w PMA.
* Families not willing to participate.

Primary outcomes:
measure: The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).
timeFrame: Each participant will be assessed from birth to the 54 weeks PMA.
Secondary outcomes:
measure: Motor development by Hammersmith Infant Neurological Scale (HINE).
timeFrame: 6 months CA
measure: Global development by Bayley III
timeFrame: 12 months CA
Other outcomes:
measure: Describe families experiences with the MIT-PB
timeFrame: 6 months CA
measure: Study family's participation and treatment adherence
timeFrame: 6 months CA
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Girona
country: Spain
facility: Hospital Universitari Josep Trueta de Girona
Study officials:
affiliation: International University of Catalonia
name: Susana Trallero, MsC
role: PRINCIPAL_INVESTIGATOR
References: