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

Not Applicable

Recruiting

• Conditions: Premature Birth; Risk; Early Intervention
• Interventions: Other: MIT-PB, movement imitation therapy for preterm.

• Registration Number: NCT05319158
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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).

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Study Start: 2022-04-04
• Study First Posted: 2022-04-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	MIT-PB, movement imitation therapy for preterm.	The group intervention will receive MIT-PB.

Primary Outcome Measures

Name	Time	Method
The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).	Each participant will be assessed from birth to the 54 weeks PMA.	We will videotape General Movements at 34, 38-40, 44 and 54 weeks PMA. The baseline measure( 34w) will be performed by the main researcher and an independent and experienced certified rater. This rater will be blind regarding infant group.; The assessments at 38-40, 44 and 54 weeks will be performed by the independent, blind and certified rater in order to guarantee the study validity.; The GMOS-R global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 38. The MOS global assessment can be classified as Fidgety (F), Abnormal Fidgety (AF) or Absent Fidgety (F-). On the detailed score the maximum value is 28. Higher scores in both scales are correlated with better global outcome.

Secondary Outcome Measures

Name	Time	Method
Motor development by Hammersmith Infant Neurological Scale (HINE).	6 months CA	Infants will assessed at 6 months CA by an independent neuro-pediatrician using the HINE.; It is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP)The maximum global score is 78. Higher scores indicate better neurological performance.
Global development by Bayley III	12 months CA	An independent neuropsychologists will assess Global Development by Bayley III at 12 months CA.; Bayley-III provides information about whether a child's developmental trajectory in the cognitive domain is proceeding as expected, relative to same-age peers. It also includes a motor score, and fine and gross motor subtest scores. The assessment indicates mild, moderate or severe delay.

Trial Locations

Locations (3)

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain

Hospital Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitari Josep Trueta de Girona; 🇪🇸 Girona, Spain