Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-30 @ 2:56 AM
Study NCT ID:
NCT05247450
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional-therapy & FES-therapy In-Veritas Effects Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Spinal Cord Independence Measure (SCIM) score', 'timeFrame': 'up to 10 weeks post-intervention', 'description': 'The SCIM is a clinician-administered disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently (SCIM varies from 0 (completely dependent) to 100 (completely independent).'}], 'secondaryOutcomes': [{'measure': 'Change in Manual muscle testing', 'timeFrame': 'up to 10 weeks post-intervention', 'description': 'Clinical assessment of the muscle power that varies from 0 (complete paralysis) to 5 (normal)'}, {'measure': 'change in Modified Japanese Outcome Association (mJOA) Score', 'timeFrame': 'up to 10 weeks post-intervention', 'description': 'Clinical assessment of the upper and lower extremities, and bladder function (mJOA varies from 0 \\[most impaired and disabled\\] to 18 \\[normal function\\]).'}, {'measure': 'Change in neurophysiological parameters', 'timeFrame': 'up to 10 weeks post-intervention', 'description': 'Neurophysiological parameters of neuroplasticity'}, {'measure': 'Change in Functional Magnetic Resonance Imaging (MRI)', 'timeFrame': '6 to10 weeks post-intervention', 'description': 'Functional MRI analyses will be focused on improvement of the functional connectivity within the somatosensory and motor cortices and pathways in the brain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional electrical stimulation therapy', 'Degenerative Cervical Myelopathy'], 'conditions': ['C5 Palsy']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy.', 'detailedDescription': 'This randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy. Secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and FES-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional MRI analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy\n\nExclusion Criteria:\n\n* Contraindication for FES-t\n* Contraindication for neurophysiological testing\n* Contraindication for MRI scanning\n* Uncontrolled cardiovascular conditions\n* Other medical conditions that can limit treatment protocols\n* Other neurological diseases\n* Significant persisting mental illness\n* Diagnosed learning disabilities\n* Substance abuse over 6 months prior to recruitment\n* Hearing and visual deficits sufficient to affect test performance\n* Reduced passive range of motion (ROM) of the shoulder ("frozen shoulder")\n* Inability to participate in and intensive outpatient rehabilitation program'}, 'identificationModule': {'nctId': 'NCT05247450', 'acronym': 'C-FIVE', 'briefTitle': 'Conventional-therapy & FES-therapy In-Veritas Effects Study', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Conventional-therapy & FES-therapy In-Veritas Effects Study (C-FIVE Study): Rehabilitation of the Upper Extremity for New Persistent C5 Palsy After Surgical Treatment of Patients With Degenerative Cervical Myelopathy', 'orgStudyIdInfo': {'id': '21-5580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FES-t along with conventional physiotherapy', 'description': 'Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training', 'interventionNames': ['Device: Functional electrical stimulation therapy (FES-t)', 'Other: Conventional physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional physiotherapy alone', 'description': 'Conventional physiotherapy alone (current standard of care)', 'interventionNames': ['Other: Conventional physiotherapy']}], 'interventions': [{'name': 'Functional electrical stimulation therapy (FES-t)', 'type': 'DEVICE', 'description': 'Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).', 'armGroupLabels': ['FES-t along with conventional physiotherapy']}, {'name': 'Conventional physiotherapy', 'type': 'OTHER', 'otherNames': ['Standard of Care'], 'description': 'Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy', 'armGroupLabels': ['Conventional physiotherapy alone', 'FES-t along with conventional physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 3V9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mitsue Aibe', 'role': 'CONTACT', 'email': 'Mitsue.Aibe@uhn.ca', 'phone': '4165973422', 'phoneExt': '6285'}], 'facility': 'KITE Toronto Research Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Mitsue Aibe, MD', 'role': 'CONTACT', 'email': 'Mitsue.Aibe@uhn.ca', 'phone': '4165973422', 'phoneExt': '6285'}, {'name': 'Abrity Gomes, BSc', 'role': 'CONTACT', 'email': 'Abrity.Gomes@uhn.ca', 'phone': '4165973422', 'phoneExt': '6285'}], 'overallOfficials': [{'name': 'Julio C Furlan, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KITE-TRI, University Health Network & University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}