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Recruiting NCT05319158

The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.

No phase Interventional Premature Birth Risk Early Intervention

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: MIT-PB, movement imitation therapy for preterm..
Who it may be relevant to
Registry conditions: Premature Birth, Risk, Early Intervention. Basic parameters: 22 Weeks — 32 Weeks · 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

The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.

Overview

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).

Interventions

  • Other MIT-PB, movement imitation therapy for preterm.
    The instant an infant showed CS or PR movements, the therapists (or a therapist and a parent) intervened by gently guiding the infants' limbs so as to maneuver and smoothen their movements, thereby imitating normal GM sequences as closely as possible, adding variability to the movement

Primary outcome measures

  • The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS). [Time frame: Each participant will be assessed from birth to the 54 weeks PMA.]
Secondary outcome measures (2)
  • Motor development by Hammersmith Infant Neurological Scale (HINE). [Time frame: 6 months CA]
  • Global development by Bayley III [Time frame: 12 months CA]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 3 centers
  • Hospital Sant Joan de Déu — Barcelona
  • Hospital Parc Taulí de Sabadell — Sabadell
  • Hospital Universitari Josep Trueta de Girona — Girona

Identifiers

NCT: NCT05319158 · 2021.002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗