Sensory Reeducation in Peripheral Nerve Injuries of Hand

Not Applicable

Completed

• Conditions: Median Nerve Disease; Peripheral Nerve Disease; Ulnar Nerve Disease
• Interventions: Other: Training with a mirror; Other: No mirror therapy

• Registration Number: NCT01215760
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-07-01
• Primary Completion: 2010-10
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Study Completion: 2011-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIRROR	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.
Home program	No mirror therapy	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.

Primary Outcome Measures

Name	Time	Method
sensory threshold	1 month	Semmes Weinstein monofilaments

Secondary Outcome Measures

Name	Time	Method
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength	12 months	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

Trial Locations

Locations (1)

Lucy Montoro Institute of Rehabilitation; 🇧🇷 Ribeirão Preto, São Paulo, Brazil