Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT06109350
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-01', 'size': 609491, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-09-21T23:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded with the outcome assessor blinded to the group allocation and the parent of preterm infants will be blinded since they will be scheduled for appointment on the different day. The outcome assessor will not be disclosed with the infants information, such as age , any medical diagnosis and group identification.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compare the compliance of the parents', 'timeFrame': '1, 2, and 3 months', 'description': 'Parental compliance will be measured by the ability of the parent to correctly demonstrate the home program activity when they come for follow up visit .'}], 'primaryOutcomes': [{'measure': 'Compare the motor performance using Test for Infant Motor Performance(TIMP)', 'timeFrame': '40 weeks, 1, 2, and 3 months of corrected age', 'description': 'TIMP is a validated tool to measure the motor performance from 34 weeks post menstrual age through 4 months corrected age. The 42 items on the test provides comprehensive assessment of head and trunk control and arms and legs movement. The total score of TIMP ranges from 0-142 with higher scores representing better motor outcome and lower score representing motor delay.'}], 'secondaryOutcomes': [{'measure': 'Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)', 'timeFrame': '40 weeks, 1, 2, and 3 months of corrected age', 'description': 'RNDA is a validated tool to assess the neurodevelopment from birth to 2 years. It used to assess developmental domains such as primitive reflex, gross motor, fine motor, vision, hearing, speech, cognition and behavior. The assessment can be interpreted into four categories which are no, mild, moderate and severe impairment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant, Premature']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is:\n\nWill physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.', 'detailedDescription': 'After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age.\n\nThe preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up.\n\nThe motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation.\n\nThe end point of the study is at 3 months of corrected age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born between 28 -34 weeks of gestation\n* Medically stable and off ventilator at the time of discharge from the hospital\n* Parents who consent to come for follow up\n\nExclusion Criteria:\n\n* Cortical blindness or retinopathy of prematurity causing blindness\n* Musculoskeletal/congenital abnormalities\n* Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus\n* Genetic syndrome\n* Family who do not consent\n* Parent with physical and psychological problems\n* Infants with medical devices such as NG tube and gastrostomy\n* Infants who have undergone major surgery'}, 'identificationModule': {'nctId': 'NCT06109350', 'briefTitle': 'The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'JDWNRH'}, 'officialTitle': 'The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB/Approval/PN/2023/002/564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supporting play exploration and early development intervention', 'description': 'Preterm infants will receive supporting play exploration and early developmental intervention till 3 months of corrected age.', 'interventionNames': ['Other: Supporting play exploration and early developmental intervention(SPEEDI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Preterm infants will receive standard care mostly including health education till 3 months of corrected age.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Supporting play exploration and early developmental intervention(SPEEDI)', 'type': 'OTHER', 'description': 'SPEEDI will be performed by the parents', 'armGroupLabels': ['Supporting play exploration and early development intervention']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard care will be performed by the parents', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11001', 'city': 'Thimphu', 'country': 'Bhutan', 'contacts': [{'name': 'Dinesh Pradhan, MD', 'role': 'CONTACT', 'email': 'dinesh.bhutan@gmail.com', 'phone': '+97517999472'}, {'name': 'Karma Lhaki, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)', 'geoPoint': {'lat': 27.46609, 'lon': 89.64191}}], 'overallOfficials': [{'name': 'Karma Lhaki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JDWNRH'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be maintained securely for at least five years after completion of study and shared.', 'ipdSharing': 'YES', 'description': 'Participant data will be shared after de identification', 'accessCriteria': 'To gain access to data, data requestor can email to principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JDWNRH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physiotherapist', 'investigatorFullName': 'Karma Lhaki', 'investigatorAffiliation': 'JDWNRH'}}}}