The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality. (MIT-PB)
Primary Purpose
Premature Birth, Risk
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MIT-PB, movement imitation therapy for preterm.
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth focused on measuring preterm, physiotherapy, early intervention, general movement
Eligibility Criteria
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.
Sites / Locations
- Hospital Parc Taulí de SabadellRecruiting
- Hospital Universitari Josep Trueta de GironaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
control group
Arm Description
The group intervention will receive MIT-PB.
The control group will receive standard care
Outcomes
Primary Outcome Measures
The quality of General Movement by General Movements Optimality Score (GMOS) 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 global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 42. 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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05319158
First Posted
March 31, 2022
Last Updated
September 17, 2023
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators
Parc Taulí Hospital Universitari
1. Study Identification
Unique Protocol Identification Number
NCT05319158
Brief Title
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
Acronym
MIT-PB
Official Title
The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators
Parc Taulí Hospital Universitari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
Two different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention group (n=18) will be located at Hospital Josep Trueta of Girona and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Risk
Keywords
preterm, physiotherapy, early intervention, general movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The infants will be pre-stratified according to General Movement Optimality Score (GMOs). The Control group will receive standard care and the Intervention group 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.
Masking
Outcomes Assessor
Masking Description
The assessments for the main outcome will be performed by a blinded expert.
Allocation
Non-Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The group intervention will receive MIT-PB.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group will receive standard care
Intervention Type
Other
Intervention Name(s)
MIT-PB, movement imitation therapy for preterm.
Intervention Description
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
Primary Outcome Measure Information:
Title
The quality of General Movement by General Movements Optimality Score (GMOS) and Motor Optimality Score (MOS).
Description
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 global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 42. 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 Outcome Measure Information:
Title
Motor development by Hammersmith Infant Neurological Scale (HINE).
Description
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
Title
Global development by Bayley III
Description
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 Pre-specified Outcome Measures:
Title
Describe families experiences with the MIT-PB
Description
• 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
Title
Study family's participation and treatment adherence
Description
Parents will get a software application in order to register the number of treatments achieved during the intervention period.
Time Frame
6 months CA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Trallero, MsC
Phone
675255810
Email
sue.trallero@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Perapoch, Dr
Phone
620015414
Email
"Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Trallero, MsC
Organizational Affiliation
International University of Catalonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Parc Taulí de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Trallero, MsC
Phone
675255810
Email
sue.trallero@gmail.com
First Name & Middle Initial & Last Name & Degree
Monica Domingo, Dr
Phone
699273285
Email
Monica Domingo Puiggrós <mdomingo@tauli.cat>
Facility Name
Hospital Universitari Josep Trueta de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Trallero, MsC
Phone
675255810
Email
sue.trallero@gmail.com
First Name & Middle Initial & Last Name & Degree
Josep Perapoch, Dr
Phone
620015414
Email
"Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
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