Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 9:38 PM
Study NCT ID:
NCT03112434
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Elastography in Spastic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Elasticity', 'timeFrame': 'From immediate pre-injection to 1 month post-injection.', 'description': 'Change in muscle elasticity (in kilopascal )'}, {'measure': 'Muscle Elasticity', 'timeFrame': 'From immediate pre-injection to 1 month post-injection.', 'description': 'Change in muscle elasticity (in m/s)'}], 'secondaryOutcomes': [{'measure': 'Functional measures', 'timeFrame': 'immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.', 'description': 'Functional measures (MAS)'}, {'measure': 'Functional measures', 'timeFrame': 'immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.', 'description': 'Functional measures (PROM)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unilateral Spastic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with unilateral spastic CP with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent. Consent may be obtained from a parent or legal guardian, as applicable.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.\n* Consent may be obtained from a parent or legal guardian, as applicable.\n\nExclusion Criteria:\n\n* Prior surgical procedure in the affected upper extremity\n* Unrelated orthopedic injury to the affected upper extremity\n* Current oral or intrathecal antispasticity therapy\n* Prior Botulinum toxin type A injection in preceding 6 months'}, 'identificationModule': {'nctId': 'NCT03112434', 'briefTitle': 'Muscle Elastography in Spastic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy', 'orgStudyIdInfo': {'id': '2016-628'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'description': 'Botox injection in upper extremity for spasticity in pediatric CP patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radiological Society of North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}