Movement Imitation Therapy for Preterm Babies (MIT-PB) - A Pilot Study

Summary

Background: Very preterm babies are at high risk for developmental disorders. Prechtl's General Movements (GMs) Assessment is a valuable and reliable tool in infants until three months corrected age for predicting their further developmental difficulties, particularly cerebral palsy. However, a specific therapeutic intervention based on this assessment, has not yet been defined. Soloveichick et al. (2019) described the Movement Imitation Therapy for Preterm Babies (MIT-PB) as a promising novel approach based on the model of GMs and the current knowledge of brain development.

Study design and objectives: The present pilot prospective controlled intervention study aims to clarify whether preterm infants born with a gestational age (GA) \<32 0/7 weeks showing abnormal GMs at 33-34 weeks postmenstrual age (PMA) differ in their neurodevelopmental outcome at three and 24 months corrected age depending on whether they were treated with usual care physiotherapy or additionally with MIT-PB.

Methods: The participants are recruited at two study sights over 18 months, whereby 40 participants per group are estimated. MIT-PB starts at the NICU and is continued until 52 weeks PMA. The parents are introduced in the method in order to take over a part of the treatment right from the beginning and continue after discharge. The essential content of MIT-PB is to manually guide the infant's abnormal movements into movements as similar as possible to normal GMs.

The primary outcome is the Motor Optimality Score Revised (MOS-R) at three months corrected age. The analysis for the primary endpoint (MOS-R at T2) will be conducted using an analysis of covariance (ANCOVA) with the treatment group (intervention/control) as fixed factor and GMOS at T0 (baseline) as covariate. Several covariates are included in the analysis. Furthermore, neuromotor outcome at term (GMOS) and at two years corrected age (Bayley Scales of Infant and Toddler Development III), as well as parental self-efficacy (Perceived Maternal Parental Self-efficacy tool(PMP S-E)) and dose-response of MIT-PB are evaluated.

Conditions

• Preterm Birth
• Early Intervention
• General Movements

Interventions

OTHER

Movement Imitation Therapy for Preterm Babies (MIT-PB)

Dr. Marina Soloveichick's Movement Imitation Therapy for Preterm Babies (MIT-PB) uses the possibility of modulating the Central Pattern Generator via the sensory afferents in infants with less variability and reduced complexity of movements. The essential content of the treatment method is to manually guide the infant's stiff and cramped movements into movements as close as possible to normal, fluent, variable GMs. Due to the resulting variability and complexity of the sensory feedback, a modulation of the CPG that is as normalised as possible, should be influenced via this approach. In the report by Soloveichick et al. 2019, MIT-PB was used in four infants with very abnormal General Movements (cramped synchronised). Although they were at high-risk for developing cerenral palsy, all participants showed normal neurodevelopmental outcome by the age of two, which is consequently attributed to MIT-PB.

OTHER

Usual care Physiotherapy

The main goal of usual care physiotherapy at the NICU is to achieve the best possible neuromotor and neuropsychological development for the patients. For this purpose, various interventions, therapy concepts and assessments are applied on an individual, patient-oriented basis. To make sure that Usual care Physiotherapy is comparable between both study sites it was defined and further described in the TIDieRchecklists prior to start of the study.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University of Zurich

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2026-05-31

Completion

2028-12-31

Countries

• Switzerland

Study Locations