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
  Purpose

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.


Condition Intervention
Median Nerve
Ulnar Nerve Disease
Peripheral Nerve Disease
Other: Training with a mirror
Other: No mirror therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proposal of Sensory Reeducation in Peripheral Nerve Injuries of Median and Ulnar Nerves of the Hand: RANDOMIZED CONTROLLED CLINICAL STUDY

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • sensory threshold [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Semmes Weinstein monofilaments


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Alternative stimuli for sensory reeducation
  • Mirror therapy
  • 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215760

Contacts
Contact: Marisa CR Fonseca, PhD +551636024769 marisa@fmrp.usp.br
Contact: Valéria MC Elui, PhD +55163024414 velui@fmrp.usp.br

Locations
Brazil
Lucy Montoro Institute of Rehabilitation Recruiting
Ribeirão Preto, São Paulo, Brazil, 14048900
Contact: Hélio Machado, PhD    551636022948    irlm@hcrp.fmrp.usp.br   
Principal Investigator: Marisa CR Fonseca, PhD         
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Marisa CR Fonseca, PhD University of São Paulo
  More Information

Additional Information:
Publications:
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.
Lundborg G. Nerve injury and repair - regeneration, reconstruction and cortical remodeling. Elsevier, Churchill Livingstone, 2a . ed. Cap.8, 9, 10 e 11, 198-244.
DELLON, A.L.; Somatosensory testing and rehabilitation. The American Occupational Ther Ass, Inc. chapter:11, 246-293, 1997.

Responsible Party: Marisa de Cássia Registro Fonseca, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01215760     History of Changes
Other Study ID Numbers: MFonseca
Study First Received: July 1, 2010
Last Updated: October 5, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
peripheral nerve injury
sensory reeducation
brain plasticity
training with a mirror
rehabilitation

Additional relevant MeSH terms:
Nervous System Diseases
Peripheral Nervous System Diseases
Ulnar Neuropathies
Wounds and Injuries
Neuromuscular Diseases
Mononeuropathies

ClinicalTrials.gov processed this record on July 10, 2014