Sensory Reeducation in Peripheral Nerve Injuries of Hand

NCT01215760 | Completed DMC

• 1 other identifier: MFonseca
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Median Nerve Disease; Ulnar Nerve Disease; Peripheral Nerve Disease

Keywords

peripheral nerve injury; sensory reeducation; brain plasticity; training with a mirror; rehabilitation

Outcome Measures

Primary Outcomes (1)

• sensory threshold

  Semmes Weinstein monofilaments

  1 month

Secondary Outcomes (3)

• sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength

  3 months

• sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength

  6 months

• sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength

  12 months

Study Arms (2)

MIRROR

ACTIVE COMPARATOR

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.

Other: Training with a mirror

Home program

ACTIVE COMPARATOR

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.

Other: No mirror therapy

Interventions

Training with a mirror 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.

Also known as: Alternative stimuli for sensory reeducation, Mirror therapy, Home program

MIRROR

No mirror therapy 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.

Also known as: home program, classic program, standard program

Home program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Lucy Montoro Institute of Rehabilitation

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (34)

• 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: 16019738 RESULT

• 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.

  PMID: 12625396 RESULT

• 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.

  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.

  PMID: 11386766 RESULT

• 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: 10811759 RESULT

• 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: 9862262 RESULT

• 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: 8994006 RESULT

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

  PMID: 15217330 RESULT

• 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: 11533734 RESULT

• 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: 11580891 RESULT

• 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: 1843843 RESULT

• 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: 15785841 RESULT

• 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: 11762726 RESULT

• 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: 9680023 RESULT

• 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: 8676027 RESULT

• 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: 8393727 RESULT

• 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: 1725057 RESULT

• 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: 14641646 RESULT

• 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: 10961548 RESULT

• 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: 10194002 RESULT

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

  PMID: 15647628 RESULT

• 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: 15862365 RESULT

• 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: 9285584 RESULT

• 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: 8441009 RESULT

• 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: 1301372 RESULT

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

  PMID: 7067267 RESULT

• 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: 9602967 RESULT

• 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.

  PMID: 15068920 RESULT

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

  RESULT

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

  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.

  RESULT

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

  RESULT

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

  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.

  PMID: 26786080 DERIVED

Related Links

• School of Medicine - University of são Paulo

MeSH Terms

Conditions

Median Neuropathy; Ulnar Neuropathies; Peripheral Nervous System Diseases; Peripheral Nerve Injuries

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Marisa CR Fonseca, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: October 6, 2010
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

BR (1)