Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 9:59 AM
Study NCT ID:
NCT06192134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Passive Motion Device for Children With Arthrogryposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001176', 'term': 'Arthrogryposis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot study of intervention compared to historic controls'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion', 'timeFrame': '2 weeks', 'description': 'knee range of motion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthrogryposis']}, 'descriptionModule': {'briefSummary': 'The Investigators are investigating a continuous passive motion device to exercise the knee of young children with arthrogryposis after they have had knee surgery.', 'detailedDescription': 'The investigators will measure the effect of continuous passive motion (CPM) of the knee joint post-surgery on young children with arthrogryposis. The investigators have developed a motorized brace that will move the joint through a prescribed range of motion and speed while the subject is seated. The objective of this pilot study is to develop the device from subject feedback and determine the right dose and speed of CPM to provide. CPM is routinely used for adults and older children after surgery to maintain range of motion. The machines used are too large for young children therefore the investigators have developed a prototype for small sized kids that will exercise their knee joint post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with arthrogryposis\n* Children between 3 and 7 years of age\n* Children who have had recent knee surgery\n\nExclusion Criteria:\n\n* Children older than 7\n* Children unable to cooperate with protocol steps'}, 'identificationModule': {'nctId': 'NCT06192134', 'briefTitle': 'Continuous Passive Motion Device for Children With Arthrogryposis', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Continuous Passive Motion Device for Children With Arthrogryposis', 'orgStudyIdInfo': {'id': '1798457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPM group', 'description': 'group receiving CPM therapy', 'interventionNames': ['Device: CPM device']}], 'interventions': [{'name': 'CPM device', 'type': 'DEVICE', 'description': 'CPM brace', 'armGroupLabels': ['CPM group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tariq Rahman', 'role': 'CONTACT', 'email': 'trahman@nemours.org', 'phone': '302 651 6831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Research Engineer', 'investigatorFullName': 'Tariq Rahman', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}