Sensory Reeducation in Peripheral Nerve Injuries of Hand (HandtherRCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01215760
First received: July 1, 2010
Last updated: October 5, 2010
Last verified: September 2010

July 1, 2010
October 5, 2010
March 2009
October 2010   (final data collection date for primary outcome measure)
sensory threshold [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Semmes Weinstein monofilaments
Same as current
Complete list of historical versions of study NCT01215760 on ClinicalTrials.gov Archive Site
  • sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
Sensory Reeducation in Peripheral Nerve Injuries of Hand
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Median Nerve
  • Ulnar Nerve Disease
  • Peripheral Nerve Disease
  • 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:
    • Alternative stimuli for sensory reeducation
    • Mirror therapy
    • Home program
  • 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
  • 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.
    Intervention: Other: Training with a mirror
  • 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.
    Intervention: Other: No mirror therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marisa CR Fonseca, PhD +551636024769 marisa@fmrp.usp.br
Contact: Valéria MC Elui, PhD +55163024414 velui@fmrp.usp.br
Brazil
 
NCT01215760
MFonseca
Yes
Marisa de Cássia Registro Fonseca, University of Sao Paulo
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Marisa CR Fonseca, PhD University of São Paulo
University of Sao Paulo
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP