Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 11:11 AM
Study NCT ID:
NCT01215760
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Reeducation in Peripheral Nerve Injuries of Hand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020424', 'term': 'Ulnar Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'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': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensory threshold', 'timeFrame': '1 month', 'description': 'Semmes Weinstein monofilaments'}], 'secondaryOutcomes': [{'measure': 'sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength', 'timeFrame': '3 months', 'description': 'Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale'}, {'measure': 'sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength', 'timeFrame': '6 months', 'description': 'Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale'}, {'measure': 'sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength', 'timeFrame': '12 months', 'description': 'Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peripheral nerve injury', 'sensory reeducation', 'brain plasticity', 'training with a mirror', 'rehabilitation'], 'conditions': ['Median Nerve Disease', 'Ulnar Nerve Disease', 'Peripheral Nerve Disease']}, 'referencesModule': {'references': [{'pmid': '16019738', 'type': 'RESULT', 'citation': 'Rosen B, Lundborg G. Training with a mirror in rehabilitation of the hand. Scand J Plast Reconstr Surg Hand Surg. 2005;39(2):104-8. doi: 10.1080/02844310510006187.'}, {'pmid': '12625396', 'type': 'RESULT', 'citation': 'Rosen B, Lundborg G. Early use of artificial sensibility to improve sensory recovery after repair of the median and ulnar nerve. Scand J Plast Reconstr Surg Hand Surg. 2003;37(1):54-7. doi: 10.1080/alp.37.1.54.57.'}, {'type': 'RESULT', 'citation': 'Rosén B, Balkenius C, Lundborg G. Sensory re-education today and tomorrow: a review of evolving concepts. British Journal of Hand Therapy. v. 8, p. 48-56, 2003.'}, {'pmid': '11386766', 'type': 'RESULT', 'citation': 'Rosen B, Lundborg G. The long term recovery curve in adults after median or ulnar nerve repair: a reference interval. J Hand Surg Br. 2001 Jun;26(3):196-200. doi: 10.1054/jhsb.2001.0567.'}, {'pmid': '10811759', 'type': 'RESULT', 'citation': 'Rosen B, Lundborg G. A model instrument for the documentation of outcome after nerve repair. J Hand Surg Am. 2000 May;25(3):535-43. doi: 10.1053/jhsu.2000.6458.'}, {'pmid': '9862262', 'type': 'RESULT', 'citation': 'Rosen B, Lundborg G. A new tactile gnosis instrument in sensibility testing. J Hand Ther. 1998 Oct-Dec;11(4):251-7. doi: 10.1016/s0894-1130(98)80020-3.'}, {'pmid': '8994006', 'type': 'RESULT', 'citation': 'Rosen B. Recovery of sensory and motor function after nerve repair. A rationale for evaluation. J Hand Ther. 1996 Oct-Dec;9(4):315-27. doi: 10.1016/s0894-1130(96)80037-8.'}, {'pmid': '15217330', 'type': 'RESULT', 'citation': 'Rizzolatti G, Craighero L. The mirror-neuron system. Annu Rev Neurosci. 2004;27:169-92. doi: 10.1146/annurev.neuro.27.070203.144230.'}, {'pmid': '11533734', 'type': 'RESULT', 'citation': 'Rizzolatti G, Fogassi L, Gallese V. Neurophysiological mechanisms underlying the understanding and imitation of action. Nat Rev Neurosci. 2001 Sep;2(9):661-70. doi: 10.1038/35090060. No abstract available.'}, {'pmid': '11580891', 'type': 'RESULT', 'citation': 'Rizzolatti G, Luppino G. The cortical motor system. Neuron. 2001 Sep 27;31(6):889-901. doi: 10.1016/s0896-6273(01)00423-8.'}, {'pmid': '1843843', 'type': 'RESULT', 'citation': 'Pons TP, Garraghty PE, Ommaya AK, Kaas JH, Taub E, Mishkin M. Massive cortical reorganization after sensory deafferentation in adult macaques. Science. 1991 Jun 28;252(5014):1857-60. doi: 10.1126/science.1843843.'}, {'pmid': '15785841', 'type': 'RESULT', 'citation': 'Orfale AG, Araujo PM, Ferraz MB, Natour J. Translation into Brazilian Portuguese, cultural adaptation and evaluation of the reliability of the Disabilities of the Arm, Shoulder and Hand Questionnaire. Braz J Med Biol Res. 2005 Feb;38(2):293-302. doi: 10.1590/s0100-879x2005000200018. Epub 2005 Feb 15.'}, {'pmid': '11762726', 'type': 'RESULT', 'citation': 'Novak CB. Evaluation of hand sensibility: a review. J Hand Ther. 2001 Oct-Dec;14(4):266-72. doi: 10.1016/s0894-1130(01)80004-1.'}, {'pmid': '9680023', 'type': 'RESULT', 'citation': 'Noble J, Munro CA, Prasad VS, Midha R. Analysis of upper and lower extremity peripheral nerve injuries in a population of patients with multiple injuries. J Trauma. 1998 Jul;45(1):116-22. doi: 10.1097/00005373-199807000-00025.'}, {'pmid': '8676027', 'type': 'RESULT', 'citation': 'McAllister RM, Gilbert SE, Calder JS, Smith PJ. The epidemiology and management of upper limb peripheral nerve injuries in modern practice. J Hand Surg Br. 1996 Feb;21(1):4-13. doi: 10.1016/s0266-7681(96)80004-0.'}, {'pmid': '8393727', 'type': 'RESULT', 'citation': 'Merzenich MM, Jenkins WM. Reorganization of cortical representations of the hand following alterations of skin inputs induced by nerve injury, skin island transfers, and experience. J Hand Ther. 1993 Apr-Jun;6(2):89-104. doi: 10.1016/s0894-1130(12)80290-0.'}, {'pmid': '1725057', 'type': 'RESULT', 'citation': 'Ciechomska A, Kotwica Z. [Aphasia without alexia after surgical treatment of aneurysm of the right middle cerebral artery--incomplete lateralization of verbal functions?]. Neurol Neurochir Pol. 1991 Jul-Aug;25(4):516-20. Polish.'}, {'pmid': '14641646', 'type': 'RESULT', 'citation': 'Lundborg G. Richard P. Bunge memorial lecture. Nerve injury and repair--a challenge to the plastic brain. J Peripher Nerv Syst. 2003 Dec;8(4):209-26. doi: 10.1111/j.1085-9489.2003.03027.x.'}, {'pmid': '10961548', 'type': 'RESULT', 'citation': 'Lundborg G. Brain plasticity and hand surgery: an overview. J Hand Surg Br. 2000 Jun;25(3):242-52. doi: 10.1054/jhsb.1999.0339.'}, {'pmid': '10194002', 'type': 'RESULT', 'citation': 'Lundborg G, Rosen B, Lindberg S. Hearing as substitution for sensation: a new principle for artificial sensibility. J Hand Surg Am. 1999 Mar;24(2):219-24. doi: 10.1053/jhsu.1999.0219.'}, {'pmid': '15647628', 'type': 'RESULT', 'citation': 'Johansson BB. Brain plasticity in health and disease. Keio J Med. 2004 Dec;53(4):231-46. doi: 10.2302/kjm.53.231.'}, {'pmid': '15862365', 'type': 'RESULT', 'citation': 'Jerosch-Herold C. Assessment of sensibility after nerve injury and repair: a systematic review of evidence for validity, reliability and responsiveness of tests. J Hand Surg Br. 2005 Jun;30(3):252-64. doi: 10.1016/j.jhsb.2004.12.006.'}, {'pmid': '9285584', 'type': 'RESULT', 'citation': 'di Pellegrino G, Ladavas E, Farne A. Seeing where your hands are. Nature. 1997 Aug 21;388(6644):730. doi: 10.1038/41921. No abstract available.'}, {'pmid': '8441009', 'type': 'RESULT', 'citation': 'di Pellegrino G, Wise SP. Visuospatial versus visuomotor activity in the premotor and prefrontal cortex of a primate. J Neurosci. 1993 Mar;13(3):1227-43. doi: 10.1523/JNEUROSCI.13-03-01227.1993.'}, {'pmid': '1301372', 'type': 'RESULT', 'citation': 'di Pellegrino G, Fadiga L, Fogassi L, Gallese V, Rizzolatti G. Understanding motor events: a neurophysiological study. Exp Brain Res. 1992;91(1):176-80. doi: 10.1007/BF00230027.'}, {'pmid': '7067267', 'type': 'RESULT', 'citation': 'Dellon AL, Jabaley ME. Reeducation of sensation in the hand following nerve suture. Clin Orthop Relat Res. 1982 Mar;(163):75-9.'}, {'pmid': '9602967', 'type': 'RESULT', 'citation': 'Dagum AB. Peripheral nerve regeneration, repair, and grafting. J Hand Ther. 1998 Apr-Jun;11(2):111-7. doi: 10.1016/s0894-1130(98)80007-0.'}, {'pmid': '15068920', 'type': 'RESULT', 'citation': 'Buccino G, Binkofski F, Riggio L. The mirror neuron system and action recognition. Brain Lang. 2004 May;89(2):370-6. doi: 10.1016/S0093-934X(03)00356-0.'}, {'type': 'RESULT', 'citation': 'Lundborg G. Nerve injury and repair - regeneration, reconstruction and cortical remodeling. Elsevier, Churchill Livingstone, 2a . ed. Cap.8, 9, 10 e 11, 198-244.'}, {'type': 'RESULT', 'citation': 'LUNDBORG, G. Nerve injury and repair. Edinburgh, Churchill Livingstone, 1988.'}, {'type': 'RESULT', 'citation': '9. HANSSON, T.; NYMAN, T.; NYLANDER, L.; ROSÉN, B.; BJÖRKMAN, A.; LUNDBORG, G. Visuell observation av taktil stimulering mot handen aktiverar sensomotoriska omraden I hjärnan. Svenska Läkaresällskapets Riksstämma. 2004. Abstract.'}, {'type': 'RESULT', 'citation': 'DELLON, A.L.; Somatosensory testing and rehabilitation. The American Occupational Ther Ass, Inc. chapter:11, 246-293, 1997.'}, {'type': 'RESULT', 'citation': 'DELLON, A.L. Evaluation of sensibility and re-education of sensation in the hand. Williams & Wilkins, 1981.'}, {'pmid': '26786080', 'type': 'DERIVED', 'citation': 'Paula MH, Barbosa RI, Marcolino AM, Elui VM, Rosen B, Fonseca MC. Early sensory re-education of the hand after peripheral nerve repair based on mirror therapy: a randomized controlled trial. Braz J Phys Ther. 2016 Jan-Feb;20(1):58-65. doi: 10.1590/bjpt-rbf.2014.0130. Epub 2016 Jan 19.'}], 'seeAlsoLinks': [{'url': 'http://www.fmrp.usp.br', 'label': 'School of Medicine - University of são Paulo'}]}, 'descriptionModule': {'briefSummary': 'Objectives: To develop a protocol for early treatment using sensory reeducation through the mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its comparison with the evolution of the return of skin sensitivity after a not early rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.', 'detailedDescription': 'Changes in the cerebral cortex begins soon after peripheral nerve injury resulting in overlapping cortical areas on adjacent as a result of the absence of stimuli in the area of cortical representation of the injured nerve. Sensibility reeducation is a process of reprogramming the brain through a progressive learning proposing feed the somatosensory cortex with alternative stimulus to preserve the cortical map of the hand and facilitate the sensory recovery. This study is based on the hypothesis that sensory reeducation starting in the first days after surgery by training with the mirror promotes greater preservation of the cortical map of the original hand, with better functional results. We also believe that sensory reeducation performed early with the mirror will enhance the return of sensibility, emphasizing functional reorganization with less alteration of the cortical map of the hand. Metodology: Will be included patients over 18 with injury of the median and/or ulnar nerve at the first week after surgery. Patients will be randomized into an early group with the use of mirror and a classic group of sensory reeducation. In evaluating the Rosen score will be used with motor, sensory and pain/discomfort components. The assessment instruments used were: Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years\n* male or female\n* reconstruction of peripheral nerve or ulnar median\n* primary or secondary graft through the Hospital of the Medical School of Ribeirão Preto, University São Paulo\n* possible associated tendon and skin lesions\n* flexor zones I, II, III, IV or V.\n\nExclusion Criteria:\n\n* nerve damage that may associated with multiple complex lesions, bone or joint injuries\n* presence of central nervous system injury\n* chronic diseases metabolic and degenerative rheumatic diseases, leprosy and diseases affecting the peripheral nervous system.'}, 'identificationModule': {'nctId': 'NCT01215760', 'acronym': 'HandtherRCT', 'briefTitle': 'Sensory Reeducation in Peripheral Nerve Injuries of Hand', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Proposal of Sensory Reeducation in Peripheral Nerve Injuries of Median and Ulnar Nerves of the Hand: RANDOMIZED CONTROLLED CLINICAL STUDY', 'orgStudyIdInfo': {'id': 'MFonseca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MIRROR', 'description': 'Early sensory reeducation group, started at the first week postoperatively, using specific guidelines using the mirror training and stimulation of the contralateral side. Initially, the stimulation will be unilateral and later bilateral, after the removal of the splint in 4 weeks.', 'interventionNames': ['Other: Training with a mirror']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home program', 'description': 'The classical group iniciates after 16 weeks postoperatively and follow a standard home protocol for sensory reeducation. It begins with recognition of textures and objects, and specific rehabilitation, if any associated injuries.', 'interventionNames': ['Other: No mirror therapy']}], 'interventions': [{'name': 'Training with a mirror', 'type': 'OTHER', 'otherNames': ['Alternative stimuli for sensory reeducation', 'Mirror therapy', 'Home program'], 'description': 'Early sensory reeducation group, started at the first week postoperatively, using specific guidelines using the mirror training and stimulation of the contralateral side. Initially, the stimulation will be unilateral and later bilateral, after the removal of the splint in 4 weeks.', 'armGroupLabels': ['MIRROR']}, {'name': 'No mirror therapy', 'type': 'OTHER', 'otherNames': ['home program', 'classic program', 'standard program'], 'description': 'The classical group iniciates after 16 weeks postoperatively and follow a standard home protocol for sensory reeducation without the mirror. It begins with recognition of textures and objects, and specific rehabilitation, if any associated injuries.', 'armGroupLabels': ['Home program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Lucy Montoro Institute of Rehabilitation', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Marisa CR Fonseca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marisa de Cassia Registro Fonseca', 'investigatorAffiliation': 'University of Sao Paulo'}}}}