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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Risk
• Intervention / Treatment: Other: MIT-PB, movement imitation therapy for preterm.

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.

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

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana Trallero, MsC; Phone Number: 675255810; Email: sue.trallero@gmail.com
• Study Contact Backup: Name: Josep Perapoch, Dr; Phone Number: 620015414; Email: "Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>

Study Locations

• Spain
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Universitari Josep Trueta de Girona
    • Contact: Susana Trallero, MsC; Phone Number: 675255810; Email: sue.trallero@gmail.com
    • Contact: Josep Perapoch, Dr; Phone Number: 620015414; Email: "Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Hospital Parc Taulí de Sabadell
      • Contact: Susana Trallero, MsC; Phone Number: 675255810; Email: sue.trallero@gmail.com
      • Contact: Monica Domingo, Dr; Phone Number: 699273285; Email: Monica Domingo Puiggrós <mdomingo@tauli.cat>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 9 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The group intervention will receive MIT-PB.	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
No Intervention: control group; The control group will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of General Movement by General Movements Optimality Score (GMOS) and Motor Optimality Score (MOS).	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 global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 42. 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.	Each participant will be assessed from birth to the 54 weeks PMA.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor development by Hammersmith Infant Neurological Scale (HINE).	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.	6 months CA
Global development by Bayley III	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.	12 months CA

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe families experiences with the MIT-PB	• Families will fill up a questionnaire at the end of the intervention to give their opinion about their experience with the therapy.	6 months CA
Study family's participation and treatment adherence	Parents will get a software application in order to register the number of treatments achieved during the intervention period.	6 months CA

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Collaborators: Hospital Parc Taulí, Sabadell
• Investigators: Principal Investigator: Susana Trallero, MsC, International University of Catalonia

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: preterm, physiotherapy, early intervention, general movement
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 2021-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No