Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-06-26 @ 4:45 AM
Study NCT ID:
NCT05319158
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessments for the main outcome will be performed by a blinded expert.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.\n\nMotor assessment will be carried out at 6 months Corrected Age (CA) and a global assessment at 12 months CA.\n\nThose assessments will be performed by independent and blind professionals at their corresponding Hospitals.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Describe families experiences with the MIT-PB', 'timeFrame': '6 months CA', 'description': '• Families will fill up a questionnaire at the end of the intervention to give their opinion about their experience with the therapy.'}, {'measure': "Study family's participation and treatment adherence", 'timeFrame': '6 months CA', 'description': 'Parents will get a software application in order to register the number of treatments achieved during the intervention period.'}], 'primaryOutcomes': [{'measure': 'The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).', 'timeFrame': 'Each participant will be assessed from birth to the 54 weeks PMA.', '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.\n\nThe 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.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Motor development by Hammersmith Infant Neurological Scale (HINE).', 'timeFrame': '6 months CA', 'description': 'Infants will assessed at 6 months CA by an independent neuro-pediatrician using the HINE.\n\nIt 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.'}, {'measure': 'Global development by Bayley III', 'timeFrame': '12 months CA', 'description': "An independent neuropsychologists will assess Global Development by Bayley III at 12 months CA.\n\nBayley-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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal therapy', 'general movements', 'high risk neurodevelopment', 'physiotherapy'], 'conditions': ['Premature Birth', 'Risk', 'Early Intervention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nStandardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA), 54 weeks PMA, 6 months, and 12 months.\n\nA qualitative study has been designed to assess the physiotherapy performance and parents' experience.\n\nThree 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '22 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants born before 32w GA and less than 1500g weight.\n* Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual age (PMA).\n* Families able to understand/speak Catalan, Spanish or English.\n* Families willing to participate who have the informed consent\n\nExclusion Criteria:\n\n* Infants with congenital abnormalities and/or genetic disorders\n* Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36 weeks PMA.\n* Infants with Normal General Movements at 34-36 w PMA.\n* Families not willing to participate.'}, 'identificationModule': {'nctId': 'NCT05319158', 'acronym': 'MIT-PB', 'briefTitle': "The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.", 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.', 'orgStudyIdInfo': {'id': '2021.002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The group intervention will receive MIT-PB.', 'interventionNames': ['Other: MIT-PB, movement imitation therapy for preterm.']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The control group will receive standard care'}], 'interventions': [{'name': 'MIT-PB, movement imitation therapy for preterm.', 'type': 'OTHER', '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", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08950', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Trallero Pediatric physical therapist', 'role': 'CONTACT', 'email': 'susana.trallero@sjd.es', 'phone': '+34 675255810'}], 'facility': 'Hospital Sant Joan de Déu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'BARCELONA', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Trallero, MsC', 'role': 'CONTACT', 'email': 'sue.trallero@gmail.com', 'phone': '675255810'}, {'name': 'Monica Domingo, Dr', 'role': 'CONTACT', 'email': 'Monica Domingo Puiggrós <mdomingo@tauli.cat>', 'phone': '699273285'}], 'facility': 'Hospital Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '17007', 'city': 'Girona', 'state': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Trallero, MsC', 'role': 'CONTACT', 'email': 'sue.trallero@gmail.com', 'phone': '675255810'}, {'name': 'Josep Perapoch, Dr', 'role': 'CONTACT', 'email': '"Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat>', 'phone': '620015414'}], 'facility': 'Hospital Universitari Josep Trueta de Girona', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'centralContacts': [{'name': 'Susana Trallero, MsC', 'role': 'CONTACT', 'email': 'sue.trallero@gmail.com', 'phone': '34 + 675255810'}, {'name': 'Josep Perapoch, Dr', 'role': 'CONTACT', 'email': 'jperapoch.girona.ics@gencat.cat', 'phone': '620015414'}], 'overallOfficials': [{'name': 'Susana Trallero, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International University of Catalonia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sant Joan de Deu', 'class': 'OTHER'}, {'name': 'Hospital Parc Taulí (Sabadell, Barcelona)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate, MsC, Physiotherapist Susana Trallero Rodríguez', 'investigatorFullName': 'Susana Trallero Rodríguez', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}