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

Premature Birth Clinical Trial

— MIT-PB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319158
• Other study ID #: 2021-2025
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Susana Trallero, MsC
• Phone: 675255810
• Email: sue.trallero[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Risk

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Josep Trueta de Girona	Girona
Spain	Hospital Parc Taulí de Sabadell	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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