Sensory Reeducation in Peripheral Nerve Injuries of Hand (HandtherRCT)

May 26, 2015 updated by: Marisa de Cassia Registro Fonseca, University of Sao Paulo

Proposal of Sensory Reeducation in Peripheral Nerve Injuries of Median and Ulnar Nerves of the Hand: RANDOMIZED CONTROLLED CLINICAL STUDY

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048900
        • Lucy Montoro Institute of Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: 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.
Other Names:
  • Mirror therapy
  • Alternative stimuli for sensory reeducation
  • Home program
ACTIVE_COMPARATOR: 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.
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.
Other Names:
  • home program
  • classic program
  • standard program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory threshold
Time Frame: 1 month
Semmes Weinstein monofilaments
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
Time Frame: 3 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
3 months
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
Time Frame: 6 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
6 months
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (ESTIMATE)

October 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFonseca

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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