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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-32
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MIT-PB, movement imitation therapy for preterm.

    Other intervention

    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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Motor development by Hammersmith Infant Neurological Scale (HINE).

Infants will assessed at 6 months CA by an independent neuro-pediatrician using the HINE. It is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP)The maximum global score is 78. Higher scores indicate better neurological performance.

Time frame
6 months CA
2

Global development by Bayley III

An independent neuropsychologists will assess Global Development by Bayley III at 12 months CA. Bayley-III provides information about whether a child's developmental trajectory in the cognitive domain is proceeding as expected, relative to same-age peers. It also includes a motor score, and fine and gross motor subtest scores. The assessment indicates mild, moderate or severe delay.

Time frame
12 months CA

Other outcomes

1

Describe families experiences with the MIT-PB

• Families will fill up a questionnaire at the end of the intervention to give their opinion about their experience with the therapy.

Time frame
6 months CA
2

Study family's participation and treatment adherence

Parents will get a software application in order to register the number of treatments achieved during the intervention period.

Time frame
6 months CA

Sponsors and contacts

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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Lead sponsor

Hospital Sant Joan de Deu

Collaborator

Hospital Parc Taulí (Sabadell, Barcelona)

Collaborator