Sensory Reeducation in Peripheral Nerve Injuries of Hand

NCT ID: NCT01215760

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Median Nerve Disease Ulnar Nerve Disease Peripheral Nerve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MIRROR

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.

Group Type ACTIVE_COMPARATOR

Training with a mirror

Intervention Type OTHER

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.

Home program

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.

Group Type ACTIVE_COMPARATOR

No mirror therapy

Intervention Type OTHER

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.

Interventions

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Training with a mirror

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.

Intervention Type OTHER

No mirror therapy

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.

Intervention Type OTHER

Other Intervention Names

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Alternative stimuli for sensory reeducation Mirror therapy Home program home program classic program standard program

Eligibility Criteria

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Inclusion Criteria

* patients over 18 years
* male or female
* reconstruction of peripheral nerve or ulnar median
* primary or secondary graft through the Hospital of the Medical School of Ribeirão Preto, University São Paulo
* possible associated tendon and skin lesions
* flexor zones I, II, III, IV or V.

Exclusion Criteria

* nerve damage that may associated with multiple complex lesions, bone or joint injuries
* presence of central nervous system injury
* chronic diseases metabolic and degenerative rheumatic diseases, leprosy and diseases affecting the peripheral nervous system.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marisa de Cassia Registro Fonseca

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marisa CR Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Lucy Montoro Institute of Rehabilitation

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 16019738 (View on PubMed)

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.

Reference Type RESULT
PMID: 12625396 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 11386766 (View on PubMed)

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.

Reference Type RESULT
PMID: 10811759 (View on PubMed)

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.

Reference Type RESULT
PMID: 9862262 (View on PubMed)

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.

Reference Type RESULT
PMID: 8994006 (View on PubMed)

Rizzolatti G, Craighero L. The mirror-neuron system. Annu Rev Neurosci. 2004;27:169-92. doi: 10.1146/annurev.neuro.27.070203.144230.

Reference Type RESULT
PMID: 15217330 (View on PubMed)

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.

Reference Type RESULT
PMID: 11533734 (View on PubMed)

Rizzolatti G, Luppino G. The cortical motor system. Neuron. 2001 Sep 27;31(6):889-901. doi: 10.1016/s0896-6273(01)00423-8.

Reference Type RESULT
PMID: 11580891 (View on PubMed)

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.

Reference Type RESULT
PMID: 1843843 (View on PubMed)

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.

Reference Type RESULT
PMID: 15785841 (View on PubMed)

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.

Reference Type RESULT
PMID: 11762726 (View on PubMed)

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.

Reference Type RESULT
PMID: 9680023 (View on PubMed)

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.

Reference Type RESULT
PMID: 8676027 (View on PubMed)

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.

Reference Type RESULT
PMID: 8393727 (View on PubMed)

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.

Reference Type RESULT
PMID: 1725057 (View on PubMed)

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.

Reference Type RESULT
PMID: 14641646 (View on PubMed)

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.

Reference Type RESULT
PMID: 10961548 (View on PubMed)

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.

Reference Type RESULT
PMID: 10194002 (View on PubMed)

Johansson BB. Brain plasticity in health and disease. Keio J Med. 2004 Dec;53(4):231-46. doi: 10.2302/kjm.53.231.

Reference Type RESULT
PMID: 15647628 (View on PubMed)

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.

Reference Type RESULT
PMID: 15862365 (View on PubMed)

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.

Reference Type RESULT
PMID: 9285584 (View on PubMed)

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.

Reference Type RESULT
PMID: 8441009 (View on PubMed)

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.

Reference Type RESULT
PMID: 1301372 (View on PubMed)

Dellon AL, Jabaley ME. Reeducation of sensation in the hand following nerve suture. Clin Orthop Relat Res. 1982 Mar;(163):75-9.

Reference Type RESULT
PMID: 7067267 (View on PubMed)

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.

Reference Type RESULT
PMID: 9602967 (View on PubMed)

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.

Reference Type RESULT
PMID: 15068920 (View on PubMed)

Lundborg G. Nerve injury and repair - regeneration, reconstruction and cortical remodeling. Elsevier, Churchill Livingstone, 2a . ed. Cap.8, 9, 10 e 11, 198-244.

Reference Type RESULT

LUNDBORG, G. Nerve injury and repair. Edinburgh, Churchill Livingstone, 1988.

Reference Type RESULT

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.

Reference Type RESULT

DELLON, A.L.; Somatosensory testing and rehabilitation. The American Occupational Ther Ass, Inc. chapter:11, 246-293, 1997.

Reference Type RESULT

DELLON, A.L. Evaluation of sensibility and re-education of sensation in the hand. Williams & Wilkins, 1981.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 26786080 (View on PubMed)

Related Links

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http://www.fmrp.usp.br

School of Medicine - University of são Paulo

Other Identifiers

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MFonseca

Identifier Type: -

Identifier Source: org_study_id

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