Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT03191006
Status:
UNKNOWN
Last Update Posted:
2017-06-26
First Post:
2017-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Insoles on Children With Developmental Delays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2017-06-11', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline functional performance (scores) at 12 weeks', 'timeFrame': 'baseline and up to 12 weeks', 'description': 'Pediatric Outcome Data Collection Instrument'}], 'secondaryOutcomes': [{'measure': 'change from baseline physical function (time) at 12 weeks', 'timeFrame': 'baseline and up to 12 weeks', 'description': 'time of stair climbing, timed up and go, walking on level ground'}, {'measure': 'change from baseline balance (scores) at 12 weeks', 'timeFrame': 'baseline and up to 12 weeks', 'description': 'Berg balance scale'}, {'measure': 'change from baseline quality of life at 12 weeks', 'timeFrame': 'baseline and up to 12 weeks', 'description': 'Pediatric Quality of Life inventory (PedsQL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['effect', 'insoles', 'children'], 'conditions': ['Developmental Delay']}, 'descriptionModule': {'briefSummary': 'Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays', 'detailedDescription': 'A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).\n\nThe participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.\n\nThe control group will be evaluated at the baseline and up to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* developmental delays\n\nExclusion Criteria:\n\n* age less than 3 years old or older than 10 years old normal development'}, 'identificationModule': {'nctId': 'NCT03191006', 'briefTitle': 'Effects of Insoles on Children With Developmental Delays', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays', 'orgStudyIdInfo': {'id': 'SKH-8302-106-DR-28.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group: MEI BIN insoles', 'description': 'Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.', 'interventionNames': ['Device: MEI BIN insoles']}, {'type': 'NO_INTERVENTION', 'label': 'control group: without MEI BIN insoles', 'description': 'Participants in this control group will not receive a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.'}], 'interventions': [{'name': 'MEI BIN insoles', 'type': 'DEVICE', 'description': 'insoles', 'armGroupLabels': ['study group: MEI BIN insoles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111-01', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'CONTACT', 'email': 'M001052@ms.skh.org.tw', 'phone': '228332211'}], 'overallOfficials': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}