Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 9:46 AM
Study NCT ID:
NCT05628168
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2022-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2022-11-13', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy', 'timeFrame': '5-6 months', 'description': 'This study aimed to investigate neurodynamic mobilization effect on sensory and motor nerve conduction study, pain, and functional activity in patients with type 2 diabetic neuropathy and will be assessed through Katz index and NIHON KODEN EMG device.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.'], 'conditions': ['Diabetic Neuropathies']}, 'descriptionModule': {'briefSummary': 'Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.', 'detailedDescription': 'Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.\n* The participants regularly took their diabetes medications during the assessment and treatment period.\n\nExclusion Criteria:\n\n* Uncontrolled T2DM and diagnosed with T2DM for \\< 10 years.\n* Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT05628168', 'briefTitle': 'Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'The NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques.', 'interventionNames': ['Other: Neurodynamic Mobilization Techniques', 'Other: Selected Physical Therapy Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'The participants only received a selected therapy program similar to the NMG with no change in duration.', 'interventionNames': ['Other: Selected Physical Therapy Program']}], 'interventions': [{'name': 'Neurodynamic Mobilization Techniques', 'type': 'OTHER', 'description': 'The slider neurodynamic technique for the median nerve is conducted.Tensioner neurodynamic technique for the tibial nerve is conducted.', 'armGroupLabels': ['Group A']}, {'name': 'Selected Physical Therapy Program', 'type': 'OTHER', 'description': 'The participants only received a selected therapy program similar to the NMG with no change in duration.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1133', 'city': 'El-Sheikh Zayed City', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'October 6 University', 'geoPoint': {'lat': 30.04861, 'lon': 30.99056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy at department of Neurology', 'investigatorFullName': 'Ahmed Magdy Alshimy', 'investigatorAffiliation': 'October 6 University'}}}}