Sensory Reeducation in Peripheral Nerve Injuries of Hand (HandtherRCT)
Recruitment status was Recruiting
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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 |
- sensory threshold [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Semmes Weinstein monofilaments
- 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:
|
|
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:
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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 |
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| Contact: Marisa CR Fonseca, PhD | +551636024769 | marisa@fmrp.usp.br |
| Contact: Valéria MC Elui, PhD | +55163024414 | velui@fmrp.usp.br |
| 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 | |
| Principal Investigator: | Marisa CR Fonseca, PhD | University of São Paulo |
More Information
Additional Information:
Publications:
| 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:
|
Peripheral Nervous System Diseases Ulnar Neuropathies Neuromuscular Diseases Nervous System Diseases Mononeuropathies |
ClinicalTrials.gov processed this record on May 22, 2013