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

NCT07449312 | Active Not Recruiting

• 1 other identifier: BASEC 2022-01519
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Motor Optimality Score for 3- to 5-Month-Old Infants - Revised (Einspieler et al. 2019)

  The MOS-R is a video-based assessment according to Einspieler et al. 2019 for infants from 3 to 5 months old . A video recording of undisturbed, spontanious movements in supine is assessed according to the following categories and summarizes their results in the Motor Optimality List: Fidgety Movements, Observed Movement Patterns, Age-Adequate Movement Repertoire, Observed Postural Patterns and Movement Character. The MOS-R is discribed as a valid and realiable tool to predict develompental risks, such as motor and language difficulties, cerebral palcy, minor neurological dysfunction or learning difficulties.

  at three months corrected age

Secondary Outcomes (3)

• Detailed Assessment of General Movements (GMs) - During Preterm and Term Age (Einspieler et al. 2016)

  33 0/7 - 34 6/7 weeks postmenstrual age (PMA) and at term age

• Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool

  time of inclusion, at three months corrected age

• Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III)

  two years corrected age

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group is treated with Usual care Physiotherapy and MIT-PB MIT-PB: The essential content of the treatment method is to manually guide the infant's monotonous, stiff and/or cramped movements into movements as close as possible to normal, fluent, variable GMs. The infant should be awake, content (no crying, whining) and active during this process. This should be performed about five times per day for 10 min. Legal guardians are involved as soon as possible.

Other: Movement Imitation Therapy for Preterm Babies (MIT-PB); Other: Usual care Physiotherapy

Control Group

ACTIVE COMPARATOR

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.

Other: Usual care Physiotherapy

Interventions

Movement Imitation Therapy for Preterm Babies (MIT-PB) OTHER

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.

Intervention group

Usual care Physiotherapy OTHER

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.

Control Group; Intervention group

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants
• Gestational age \< 32 weeks
• GMOS ≤ 23/42 at 33 0/7 - 34 6/7 weeks PMA
• General medical condition stable to the extent that video imaging of the GMs in supine position is possible (minimal underpinning and non-invasive ventilation or oxygen support are allowed)
• Hospitalisation at the NICU at University Hospital Zurich (USZ) or Inselspital Bern
• Place of residence located in order to ensure appropriate follow-up outpatient physiotherapy treatment, if indicated
• Parent or legal guardian must be able to give informed consent as documented by signature

You may not qualify if:

• Syndromal disease
• Neuromuscular disease (e.g. myelomeningocele, spinal muscular atrophy)
• Underlying musculoskeletal disease (e.g. arthrogryposis, clubfoot)
• Participation in other studies if it is anticipated that the interventions in each case could affect the outcome of the other study
• Inability of the legal guardian to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Sponsors & Collaborators

• University of Zurich: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (15)

• Soloveichick M, Marschik PB, Gover A, Molad M, Kessel I, Einspieler C. Movement Imitation Therapy for Preterm Babies (MIT-PB): a Novel Approach to Improve the Neurodevelopmental Outcome of Infants at High-Risk for Cerebral Palsy. J Dev Phys Disabil. 2020;32(4):587-598. doi: 10.1007/s10882-019-09707-y. Epub 2019 Nov 18.

  PMID: 32669775 BACKGROUND

• Einspieler C, Bos AF, Krieber-Tomantschger M, Alvarado E, Barbosa VM, Bertoncelli N, Burger M, Chorna O, Del Secco S, DeRegnier RA, Huning B, Ko J, Lucaccioni L, Maeda T, Marchi V, Martin E, Morgan C, Mutlu A, Nogolova A, Pansy J, Peyton C, Pokorny FB, Prinsloo LR, Ricci E, Saini L, Scheuchenegger A, Silva CRD, Soloveichick M, Spittle AJ, Toldo M, Utsch F, van Zyl J, Vinals C, Wang J, Yang H, Yardimci-Lokmanoglu BN, Cioni G, Ferrari F, Guzzetta A, Marschik PB. Cerebral Palsy: Early Markers of Clinical Phenotype and Functional Outcome. J Clin Med. 2019 Oct 4;8(10):1616. doi: 10.3390/jcm8101616.

  PMID: 31590221 BACKGROUND

• Einspieler C, Marschik PB, Pansy J, Scheuchenegger A, Krieber M, Yang H, Kornacka MK, Rowinska E, Soloveichick M, Bos AF. The general movement optimality score: a detailed assessment of general movements during preterm and term age. Dev Med Child Neurol. 2016 Apr;58(4):361-8. doi: 10.1111/dmcn.12923. Epub 2015 Sep 14.

  PMID: 26365130 BACKGROUND

• Barnes CR, Adamson-Macedo EN. Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: development and validation with mothers of hospitalized preterm neonates. J Adv Nurs. 2007 Dec;60(5):550-60. doi: 10.1111/j.1365-2648.2007.04445.x.

  PMID: 17973719 BACKGROUND

• Einspieler C, Prechtl HFR, Bos AF. Prechtl's Method on the Qualitative Assessment of General Movements in Preterm, Term and Young Infants.; 2008.

  BACKGROUND

• Einspieler C, Prechtl HF. Prechtl's assessment of general movements: a diagnostic tool for the functional assessment of the young nervous system. Ment Retard Dev Disabil Res Rev. 2005;11(1):61-7. doi: 10.1002/mrdd.20051.

  PMID: 15856440 BACKGROUND

• Peyton C, Yang E, Msall ME, Adde L, Stoen R, Fjortoft T, Bos AF, Einspieler C, Zhou Y, Schreiber MD, Marks JD, Drobyshevsky A. White Matter Injury and General Movements in High-Risk Preterm Infants. AJNR Am J Neuroradiol. 2017 Jan;38(1):162-169. doi: 10.3174/ajnr.A4955. Epub 2016 Oct 27.

  PMID: 27789448 BACKGROUND

• Hadders-Algra M. Neural substrate and clinical significance of general movements: an update. Dev Med Child Neurol. 2018 Jan;60(1):39-46. doi: 10.1111/dmcn.13540. Epub 2017 Aug 23.

  PMID: 28832987 BACKGROUND

• Einspieler C, Marschik PB. Central Pattern Generators und ihre Bedeutung für die fötale Motorik. Klin Neurophysiol. 2012;43(01):16-21. doi:10.1055/s-0031-1286264

  BACKGROUND

• Anderson PJ, Treyvaud K, Spittle AJ. Early developmental interventions for infants born very preterm - what works? Semin Fetal Neonatal Med. 2020 Jun;25(3):101119. doi: 10.1016/j.siny.2020.101119. Epub 2020 May 15.

  PMID: 32446767 BACKGROUND

• Morgan C, Darrah J, Gordon AM, Harbourne R, Spittle A, Johnson R, Fetters L. Effectiveness of motor interventions in infants with cerebral palsy: a systematic review. Dev Med Child Neurol. 2016 Sep;58(9):900-9. doi: 10.1111/dmcn.13105. Epub 2016 Mar 29.

  PMID: 27027732 BACKGROUND

• Spittle AJ, Anderson PJ, Tapawan SJ, Doyle LW, Cheong JLY. Early developmental screening and intervention for high-risk neonates - From research to clinical benefits. Semin Fetal Neonatal Med. 2021 Jun;26(3):101203. doi: 10.1016/j.siny.2021.101203. Epub 2021 Jan 29.

  PMID: 33547000 BACKGROUND

• Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7.

  PMID: 27925172 BACKGROUND

• Khurana S, Kane AE, Brown SE, Tarver T, Dusing SC. Effect of neonatal therapy on the motor, cognitive, and behavioral development of infants born preterm: a systematic review. Dev Med Child Neurol. 2020 Jun;62(6):684-692. doi: 10.1111/dmcn.14485. Epub 2020 Feb 19.

  PMID: 32077096 BACKGROUND

• Albers CA, Grieve AJ. Test Review: Bayley, N. (2006). Bayley Scales of Infant and Toddler Development- Third Edition. San Antonio, TX: Harcourt Assessment. J Psychoeduc Assess. 2007;25(2):180-190. doi:10.1177/0734282906297199

  BACKGROUND

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The GMOS and MOS-R, as well as the Bayley III assessors are blinded to the intervention and the group allocation of the participants. The physiotherapists who perform the intervention in both groups do not score the assessments.The statistical analysis is done by a study statistician, who is not part of the core study team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention and control groups are recruited parallel at two different Swiss Level III NICUs: the intervention group at University Hospital Zurich (USZ) and the control group at Inselspital Bern.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

CH (1)