Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-05 @ 8:03 AM
Study NCT ID:
NCT03970395
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2019-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049068', 'term': 'Plagiocephaly, Nonsynostotic'}], 'ancestors': [{'id': 'D059041', 'term': 'Plagiocephaly'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'claudiog.priolo@gmail.com', 'phone': '0039 3471403064', 'title': 'Dr Claudio G Priolo', 'organization': 'Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first treatment (1 week post-baseline) up to end of treatment course (3 months).', 'description': 'Symptoms such as irritability occured after the Osteopathic Manipulative Therapy or Light Touch Therapy', 'eventGroups': [{'id': 'EG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy.\n\nOMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy.\n\nOMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.'}], 'classes': [{'categories': [{'title': 'ODDI score <104%', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'ODDI score >=104%', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.66', 'ciLowerLimit': '2.46', 'ciUpperLimit': '23.84', 'pValueComment': 'The threshold for statistical significance was p\\<0.5', 'estimateComment': 'Risk Difference 0.41 (IC 95; 0.25-0.53)', 'statisticalMethod': 'Risk Ratio (RR)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 3 months', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'classes': [{'categories': [{'title': 'ODDI score <104%', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'ODDI score >=104%', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '2.36', 'ciUpperLimit': '13.27', 'estimateComment': 'Risk Difference 0.47 (IC 95; 0.31-0.64)', 'statisticalMethod': 'Relative Risk (RR)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up at 1 year of age', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'classes': [{'categories': [{'title': 'ODDI score <104%', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'ODDI score >=104%', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.49', 'ciLowerLimit': '2.42', 'ciUpperLimit': '23.18', 'estimateComment': 'Risk Difference 0.44 (IC 95%; 0.27-0.60)', 'statisticalMethod': 'Risk Ratio (RR)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3 months', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the three months intervention.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'classes': [{'categories': [{'title': 'ODDI score <104%', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'ODDI score >=104%', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.91', 'ciLowerLimit': '2.12', 'ciUpperLimit': '11.38', 'estimateComment': 'Risk Difference 0.54 (IC 95; 0.36-0.72)', 'statisticalMethod': 'Risk Ratio (RR)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up at one year of age', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of Nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104\\<108 MILD Nonsynostotic Plagiocephaly ODDI score \\>=108\\<112 MODERATE Nonsynostotic Plagiocephaly ODDI score \\>= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population, defined as participants completing the one year of age follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Cranial Proportion Index (CPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'timeFrame': 'The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.', 'description': 'Change of the width and length diameter measured with Plagiocephalometry.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for lack of clinical relevance'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopaths with a specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'OG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention was performed by two osteopaths with a specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'classes': [{'title': 'Serious Adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other adverse events such as irritability', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first treatment (1 week post-baseline) up to end of treatment course (3 months).', 'description': 'Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Any Adverse Events'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopath with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'FG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, ODDI score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nThe intervention were performed by two osteopath with specific background in paediatric field.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': "Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Osteopathic Manipulative Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI )score \\>= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nThey received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'BG001', 'title': 'Light Touch Therapy Plus Repositioning Therapy', 'description': 'Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI) score \\>= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT).\n\nThey received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks.\n\nRepositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Presentation at birth', 'classes': [{'categories': [{'title': 'Cefalic', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Breech', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Trasvers', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '2657', 'spread': '945', 'groupId': 'BG000'}, {'value': '2290', 'spread': '995', 'groupId': 'BG001'}, {'value': '2473', 'spread': '970', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Mother's first pregnancy", 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple birth', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Delivery', 'classes': [{'categories': [{'title': 'Vaginal', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Assisted', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Vacuum - Forceps', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Cesarean', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Feeding', 'classes': [{'categories': [{'title': 'Maternal', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Bottle', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Mix', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sleeping', 'classes': [{'categories': [{'title': 'Supine', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Variable', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Daytime', 'classes': [{'categories': [{'title': 'Supine', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Variable', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Mother's age", 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '34.45', 'spread': '5.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Father's age", 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '37', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age end of study', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '6.15', 'spread': '1.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-19', 'size': 113753, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-01T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Infants were randomly assigned to two groups, OMT and LTT by using a random number generator, prepared in advance by an independent biostatistician. Sequentially numbered, opaque, and sealed envelopes were used.\n\nClinician-Investigators, neonatology staff, the physical therapist, and the osteopath in charge of assessment were unaware of the random list.\n\nInfants' parents, after having signed the informed consent form, chose the numbered envelope and were unaware of the random list for the whole period of study.\n\nThe two osteopaths in charge of Osteopathic manipulative therapy and Light Touch Therapy were unblinded to group assignment.\n\nClinical outcomes were assessed by a biostatistician who was not involved in the patients' clinical allocation and management."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2019-05-05', 'resultsFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-02', 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months', 'timeFrame': 'Baseline and 3 months', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.'}, {'measure': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.', 'timeFrame': 'Follow-up at 1 year of age', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.'}, {'measure': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months', 'timeFrame': 'At 3 months', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104 Nonsynostotic Plagiocephaly ODDI score \\<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.'}, {'measure': 'Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.', 'timeFrame': 'Follow-up at one year of age', 'description': 'The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly.\n\nThe category of Nonsynostotic plagiocephaly is defined by reference to the following score:\n\nODDI score \\>=104\\<108 MILD Nonsynostotic Plagiocephaly ODDI score \\>=108\\<112 MODERATE Nonsynostotic Plagiocephaly ODDI score \\>= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Cranial Proportion Index (CPI)', 'timeFrame': 'The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.', 'description': 'Change of the width and length diameter measured with Plagiocephalometry.'}, {'measure': 'Adverse Event', 'timeFrame': 'From first treatment (1 week post-baseline) up to end of treatment course (3 months).', 'description': 'Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positional Plagiocephaly, Deformational Plagiocephaly,'], 'conditions': ['Nonsynostotic Plagiocephaly']}, 'referencesModule': {'references': [{'pmid': '21187783', 'type': 'BACKGROUND', 'citation': 'Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part I: terminology, diagnosis, and etiopathogenesis. J Craniofac Surg. 2011 Jan;22(1):9-16. doi: 10.1097/SCS.0b013e3181f6c313.'}, {'pmid': '21187782', 'type': 'BACKGROUND', 'citation': 'Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part II: prevention and treatment. J Craniofac Surg. 2011 Jan;22(1):17-23. doi: 10.1097/SCS.0b013e3181f6c342.'}, {'pmid': '21726785', 'type': 'BACKGROUND', 'citation': 'Lennartsson F. Developing guidelines for child health care nurses to prevent nonsynostotic plagiocephaly: searching for the evidence. J Pediatr Nurs. 2011 Aug;26(4):348-58. doi: 10.1016/j.pedn.2010.07.003. Epub 2010 Sep 25.'}, {'pmid': '21982132', 'type': 'BACKGROUND', 'citation': 'Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011 Nov;17(4):193-8. doi: 10.1016/j.ctcp.2011.02.001. Epub 2011 Mar 5.'}, {'pmid': '16211401', 'type': 'BACKGROUND', 'citation': 'van Vlimmeren LA, Takken T, van Adrichem LN, van der Graaf Y, Helders PJ, Engelbert RH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull; a reliability study. Eur J Pediatr. 2006 Mar;165(3):149-57. doi: 10.1007/s00431-005-0011-1. Epub 2005 Oct 7.'}, {'pmid': '36451623', 'type': 'DERIVED', 'citation': 'Bagagiolo D, Priolo CG, Favre EM, Pangallo A, Didio A, Sbarbaro M, Borro T, Dacco S, Manzoni P, Farina D. A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly. Am J Perinatol. 2022 Dec;39(S 01):S52-S62. doi: 10.1055/s-0042-1758723. Epub 2022 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.', 'detailedDescription': 'Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.\n\nFour months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.\n\nEarly assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.\n\nIn paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with NSP, ODDI score of 104% or more.\n* To be at term corrected age if born prematurely.\n\nExclusion Criteria:\n\n* Synostotic Plagiocephaly\n* Infant who underwent an osteopathic manipulative treatment before the enrolment\n* Dysmorphisms\n* Syndromes\n* Congenital Muscular Torcicolis\n* Cerebral Palsy'}, 'identificationModule': {'nctId': 'NCT03970395', 'briefTitle': 'Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly', 'orgStudyIdInfo': {'id': '0074260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic manipulative therapy', 'description': 'Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh).\n\nOsteopathic Manipulative Therapy. Participant OMT group receive 6 OMTh in 3 months, as follows: first at baseline, the second after 1 week, the third after 3 weeks, and then once every 3 weeks for three more visits.', 'interventionNames': ['Other: Osteopathic manipulative therapy (OMTh)', 'Other: Repositioning therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Light Touch Therapy', 'description': 'Repositioning Therapy plus Light Touch Therapy (LTT)\n\nParticipants to the LTT group receive the LTT protocol at the same date of the OMTh group.', 'interventionNames': ['Other: Light Touch Therapy (LTT)', 'Other: Repositioning therapy']}], 'interventions': [{'name': 'Osteopathic manipulative therapy (OMTh)', 'type': 'OTHER', 'description': 'The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.', 'armGroupLabels': ['Osteopathic manipulative therapy']}, {'name': 'Light Touch Therapy (LTT)', 'type': 'OTHER', 'description': 'The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.', 'armGroupLabels': ['Light Touch Therapy']}, {'name': 'Repositioning therapy', 'type': 'OTHER', 'description': 'It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant\'s head is placed.', 'armGroupLabels': ['Light Touch Therapy', 'Osteopathic manipulative therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': "Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Claudio G Priolo, Medical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy'}, {'name': 'Daniele Farina, Medical', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PRIOLO CLAUDIO', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scuola Superiore di Osteopatia Italiana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Paediatrician', 'investigatorFullName': 'PRIOLO CLAUDIO', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}