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Sensory Reeducation in Peripheral Nerve Injuries of Hand (HandtherRCT)

Primary Purpose

Median Nerve Disease, Ulnar Nerve Disease, Peripheral Nerve Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training with a mirror
No mirror therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Median Nerve Disease focused on measuring peripheral nerve injury, sensory reeducation, brain plasticity, training with a mirror, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lucy Montoro Institute of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MIRROR

Home program

Arm 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.

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.

Outcomes

Primary Outcome Measures

sensory threshold
Semmes Weinstein monofilaments

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2010
Last Updated
May 26, 2015
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01215760
Brief Title
Sensory Reeducation in Peripheral Nerve Injuries of Hand
Acronym
HandtherRCT
Official Title
Proposal of Sensory Reeducation in Peripheral Nerve Injuries of Median and Ulnar Nerves of the Hand: RANDOMIZED CONTROLLED CLINICAL STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Median Nerve Disease, Ulnar Nerve Disease, Peripheral Nerve Disease
Keywords
peripheral nerve injury, sensory reeducation, brain plasticity, training with a mirror, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRROR
Arm Type
Active Comparator
Arm 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.
Arm Title
Home program
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Training with a mirror
Other Intervention Name(s)
Alternative stimuli for sensory reeducation, Mirror therapy, Home program
Intervention 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.
Intervention Type
Other
Intervention Name(s)
No mirror therapy
Other Intervention Name(s)
home program, classic program, standard program
Intervention 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.
Primary Outcome Measure Information:
Title
sensory threshold
Description
Semmes Weinstein monofilaments
Time Frame
1 month
Secondary Outcome Measure Information:
Title
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
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
Time Frame
3 months
Title
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
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
Time Frame
6 months
Title
sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa CR Fonseca, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucy Montoro Institute of Rehabilitation
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048900
Country
Brazil

12. IPD Sharing Statement

Citations:
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Citation
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Links:
URL
http://www.fmrp.usp.br
Description
School of Medicine - University of são Paulo

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Sensory Reeducation in Peripheral Nerve Injuries of Hand

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