Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT03191032
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2017-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Sensory Re-education of the Hand With a Sensor Glove Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory Threshold - Mann Whitney non-parametric test', 'timeFrame': 'First, Third and Sixth month post-operative', 'description': 'Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative'}, {'measure': 'Tactil Gnosis - Mann Whitney non-parametric test', 'timeFrame': 'First, Third and Sixth month post-operative', 'description': 'Tactile Gnosis was assessed by Two-point discrimination and Shape and Texture Identification Test at first, third and sixth month post-operative'}, {'measure': 'Self-report function - Mann Whitney non-parametric test', 'timeFrame': 'First, Third and Sixth month post-operative', 'description': 'Self-report function was assessed by DASH questionnaire at first, third and sixth month post-operative'}, {'measure': 'Cortical responses - fMRI data analysed by Granger Causality Map', 'timeFrame': 'Three months', 'description': 'Training group subjects were submitted to fMRI exam at third month post-operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral nerves/lesions; hands; rehabilitation; fMRI'], 'conditions': ['Peripheral Nerve Injuries']}, 'descriptionModule': {'briefSummary': 'The implementation of early sensory re-education (SR) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. The aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. After six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. Despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early SR of the hand using the integration of different sensory modalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired\n\nExclusion Criteria:\n\n* Neurological diseases\n* Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system\n* Extensive traumas in the upper limbs'}, 'identificationModule': {'nctId': 'NCT03191032', 'briefTitle': 'Early Sensory Re-education of the Hand With a Sensor Glove Model', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction', 'orgStudyIdInfo': {'id': 'Sensor glove'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'Early sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair', 'interventionNames': ['Other: Early sensory re-education of the hand with a sensor glove model']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol'}], 'interventions': [{'name': 'Early sensory re-education of the hand with a sensor glove model', 'type': 'OTHER', 'otherNames': ['Physical Therapy'], 'description': 'Training Group patients were submitted to application of a three-month protocol for early sensory re-education of the hand using the sensor glove model developed by Mendes et al. (2011). Patients also received conventional physical therapy for this type of injury in a specialized hand therapy center in a university hospital. Control Group patients received only conventional physical therapy treatment. No home sensory re-education program was established for any group and the CG patients were not submitted to any protocol for early sensory re-education of the hand.', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Raquel M Sugano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Collaborator', 'investigatorFullName': 'Marisa de Cassia Registro Fonseca', 'investigatorAffiliation': 'University of Sao Paulo'}}}}