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

NCT05319158 | Recruiting

• 1 other identifier: 2021.002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Premature Birth; Risk; Early Intervention

Keywords

neonatal therapy; general movements; high risk neurodevelopment; physiotherapy

Outcome Measures

Primary Outcomes (1)

• The quality of General Movement by General Movements Optimality Score (GMOS-R) 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-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.

  Each participant will be assessed from birth to the 54 weeks PMA.

Secondary Outcomes (2)

• Motor development by Hammersmith Infant Neurological Scale (HINE).

  6 months CA

• Global development by Bayley III

  12 months CA

Other Outcomes (2)

• Describe families experiences with the MIT-PB

  6 months CA

• Study family's participation and treatment adherence

  6 months CA

Study Arms (2)

Intervention group

EXPERIMENTAL

The group intervention will receive MIT-PB.

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

control group

NO INTERVENTION

The control group will receive standard care

Interventions

MIT-PB, movement imitation therapy for preterm. OTHER

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

Intervention group

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead
• Hospital Sant Joan de Deu: collaborator
• Hospital Parc Taulí (Sabadell, Barcelona): collaborator

Study Sites (3)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

RECRUITING

Hospital Parc Taulí de Sabadell

Sabadell, BARCELONA, 08208, Spain

RECRUITING

Hospital Universitari Josep Trueta de Girona

Girona, Girona, 17007, Spain

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Susana Trallero, MsC

  International University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Trallero, MsC

CONTACT

34 + 675255810; sue.trallero@gmail.com

Josep Perapoch, Dr

CONTACT

620015414; jperapoch.girona.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessments for the main outcome will be performed by a blinded expert.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, MsC, Physiotherapist Susana Trallero Rodríguez

Model Details: The infants will be pre-stratified according to General Movement Optimality Score (GMOs). The Control group will receive standard care and the Intervention groups will begin the therapy at 34-36w. The intervention will be explained and guided by the principal researcher and experienced Pediatric Physical therapist. Parents will conduct the intervention until the 50-52 weeks PMA. General Movement Assessment (GMA) will be performed at term, 44w and 54w PMA. Motor assessment will be carried out at 6 months Corrected Age (CA) and a global assessment at 12 months CA. Those assessments will be performed by independent and blind professionals at their corresponding Hospitals.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: April 4, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)