Early Sensory Re-education of the Hand With a Sensor Glove Model

Not Applicable

Completed

• Conditions: Peripheral Nerve Injuries
• Interventions: Other: Early sensory re-education of the hand with a sensor glove model

• Registration Number: NCT03191032
• Lead Sponsor: University of Sao Paulo

Brief Summary

The implementation of early sensory re-education (SR) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. The aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. After six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. Despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early SR of the hand using the integration of different sensory modalities.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired

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Exclusion Criteria

• Neurological diseases
• Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
• Extensive traumas in the upper limbs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training Group	Early sensory re-education of the hand with a sensor glove model	Early sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair

Primary Outcome Measures

Name	Time	Method
Cortical responses - fMRI data analysed by Granger Causality Map	Three months	Training group subjects were submitted to fMRI exam at third month post-operative
Sensory Threshold - Mann Whitney non-parametric test	First, Third and Sixth month post-operative	Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative
Tactil Gnosis - Mann Whitney non-parametric test	First, Third and Sixth month post-operative	Tactile Gnosis was assessed by Two-point discrimination and Shape and Texture Identification Test at first, third and sixth month post-operative
Self-report function - Mann Whitney non-parametric test	First, Third and Sixth month post-operative	Self-report function was assessed by DASH questionnaire at first, third and sixth month post-operative