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

I

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status

Enrolling

Conditions

Risk
Early Intervention
Premature Birth

Treatments

Other: MIT-PB, movement imitation therapy for preterm.

Study type

Interventional

Funder types

Other

Identifiers

NCT05319158
2021.002

Details and patient eligibility

About

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.

Full 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).

Enrollment

36 estimated patients

Sex

All

Ages

22 to 32 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

36 participants in 2 patient groups

Intervention group
Experimental group
Description:
The group intervention will receive MIT-PB.
Treatment:
Other: MIT-PB, movement imitation therapy for preterm.
control group
No Intervention group
Description:
The control group will receive standard care

Trial contacts and locations

3

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Central trial contact

Susana Trallero, MsC; Josep Perapoch, Dr

Data sourced from clinicaltrials.gov

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