MedDataX Logo

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

NCT ID: NCT05319158

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth Risk Early Intervention

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

neonatal therapy general movements high risk neurodevelopment physiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessments for the main outcome will be performed by a blinded expert.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

The group intervention will receive MIT-PB.

Group Type EXPERIMENTAL

MIT-PB, movement imitation therapy for preterm.

Intervention Type 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

control group

The control group will receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

22 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Hospital Parc Taulí (Sabadell, Barcelona)

UNKNOWN

Sponsor Role collaborator

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susana Trallero Rodríguez

PhD candidate, MsC, Physiotherapist Susana Trallero Rodríguez

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susana Trallero, MsC

Role: PRINCIPAL_INVESTIGATOR

International University of Catalonia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Parc Taulí de Sabadell

Sabadell, BARCELONA, Spain

Site Status RECRUITING

Hospital Universitari Josep Trueta de Girona

Girona, Girona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Susana Trallero, MsC

Role: CONTACT

Phone: 34 + 675255810

Email: [email protected]

Josep Perapoch, Dr

Role: CONTACT

Phone: 620015414

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Susana Trallero Pediatric physical therapist

Role: primary

Susana Trallero, MsC

Role: primary

Monica Domingo, Dr

Role: backup

Susana Trallero, MsC

Role: primary

Josep Perapoch, Dr

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021.002

Identifier Type: -

Identifier Source: org_study_id