Premature BirthMIT-PBNCT05319158
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
A study testing MIT-PB, movement imitation therapy for preterm. in people with Premature Birth and Risk, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Premature Birth, Risk, Early Intervention
- What is being tested?
- MIT-PB, movement imitation therapy for preterm.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesSpain
- Study dates
- 4 Apr 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Sant Joan de Déu
Barcelona, Barcelona, 08950
Susana Trallero Pediatric physical therapist, +34 675255810, susana.trallero@sjd.es
- Recruiting
Hospital Universitari Josep Trueta de Girona
Girona, Girona, 17007
Susana Trallero, MsC, 675255810, sue.trallero@gmail.com
Josep Perapoch, Dr, 620015414, "Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>
- Recruiting
Hospital Parc Taulí de Sabadell
Sabadell, BARCELONA, 08208
Susana Trallero, MsC, 675255810, sue.trallero@gmail.com
Monica Domingo, Dr, 699273285, Monica Domingo Puiggrós <mdomingo@tauli.cat>
About this study
Official title: The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
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.
Read the 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.
Three different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention groups (n=18) will be located at Hospital Josep Trueta of Girona and Hospital Sant Joan de Déu and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).
- Conditions
- Premature Birth, Risk, Early Intervention
- Being tested
- MIT-PB, movement imitation therapy for preterm.
- Keywords
- neonatal therapy, general movements, high risk neurodevelopment, physiotherapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIT-PB, movement imitation therapy for preterm.Other
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The group intervention will receive MIT-PB. Receives: Other: MIT-PB, movement imitation therapy for preterm. |
| control group | No intervention | The control group will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant will be assessed from birth to the 54 weeks PMA.
Secondary outcomes (2)
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.
Measured: 6 months CA
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.
Measured: 12 months CA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start4 Apr 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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 groups 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Parc Taulí (Sabadell, Barcelona)
- Responsible party
- Principal investigator, Susana Trallero Rodríguez, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Susana Trallero, MsC, Principal investigator, International University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319158
- Sponsor's protocol ID
- 2021.002
- Acronym
- MIT-PB
- Status last verified
- Dec 2024
- First submitted
- 31 Mar 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
- ClinicalTrials.gov ID
- NCT05319158
- Acronym / sponsor ID
- MIT-PB / 2021.002
- Conditions
- Premature Birth, Risk, Early Intervention
- Keywords
- neonatal therapy, general movements, high risk neurodevelopment, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Parc Taulí (Sabadell, Barcelona)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Three different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention groups (n=18) will be located at Hospital Josep Trueta of Girona and Hospital Sant Joan de Déu and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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 groups 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: MIT-PB, movement imitation therapy for preterm.The group intervention will receive MIT-PB. |
| control group | No intervention | –The control group will receive standard care |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIT-PB, movement imitation therapy for preterm.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 | Other | Intervention group |
Primary outcome
The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).
Time frame: Each participant will be assessed from birth to the 54 weeks PMA.
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.
2 secondary outcomes
Motor development by Hammersmith Infant Neurological Scale (HINE).
Time frame: 6 months CA
Global development by Bayley III
Time frame: 12 months CA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Trallero, MsC principal investigator
International University of Catalonia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIT-PB, movement imitation therapy for preterm. in people with Premature Birth and Risk, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Trallero, MsC (34 + 675255810, sue.trallero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS). (time frame: Each participant will be assessed from birth to the 54 weeks PMA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.