Movement Imitation Therapy for Preterm Babies (MIT-PB): What influence does this early intervention have on the neuromotor development of preterm children with atypical spontaneous motor activity (General Movements)?
Summary description of the study
The Movement Imitation Therapy for Preterm Babies (MIT-PB) by Dr. Marina Soloveichick is a new treatment method for preterm infants that has been little studied so far. This study aims to find out whether the new treatment method has a greater positive influence on neuromotor development than conventional physiotherapy. To investigate this, there will be a control group and an intervention group, each with approximately 40 children. The children included in the study from the neonatology department of Inselspital Bern form the control group. The children included in the study from the neonatology clinic of USZ in Zurich form the intervention group. The children in the control group will be treated with conventional physiotherapy. Apart from documenting the frequency and contents of the treatments, nothing will change in the treatment. The children in the intervention group will be treated with conventional physiotherapy and additionally with MIT-PB. The parents will be introduced to the treatment so that they can carry out most of the treatment independently. They will be accompanied and supported by trained physiotherapists both in the hospital and after discharge. The treatment will be carried out until the age of 52 weeks (corrected three months). All children will undergo a test at 40 weeks, corrected three months, and two years to assess the child's neuromotor development status. Parents will be asked to complete a short self-efficacy questionnaire (PMP S-E) at the beginning of the study and at the three-month check-up. The total duration of the study per child is approximately 26 months.
(BASEC)
Intervention under investigation
The children in the intervention group will be treated in addition to conventional physiotherapeutic treatment by the physiotherapist and/or by the parents with MIT-PB. The MIT-PB starts in neonatology and continues at home until the age of 52 weeks. Essential in this treatment method according to Dr. Marina Soloveichick is the manual redirection of atypical spontaneous movements towards as fluid and variable movements as possible. The child should be awake, content, and active during the treatment. The MIT-PB should be applied 5 times a day for 10 minutes.
(BASEC)
Disease under investigation
The neuromotor development of preterm children (under 32 weeks of gestation) with a high risk of mild to severe neuromotor developmental impairment.
(BASEC)
Children born before 32 weeks of gestation (in the neonatology clinic at USZ or the neonatology department of Inselspital Bern) and showing atypical General Movements (spontaneous movements) at 33-34 weeks of gestation and/or having a brain hemorrhage grade 3 or higher. (BASEC)
Exclusion criteria
Comorbidities that could further restrict the motor behavior of preterm children (such as syndromic diseases, neuromuscular diseases, or diseases affecting the musculature and/or the skeletal system) (BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
not available
Contact
Contact Person Switzerland
Stephanie Brezina
+41 44 255 92 78
ngn.mit-pb-studie@clutterusz.ch(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
04.11.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
not available
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available