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

Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Other: Early sensory re-education of the hand with a sensor glove model

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training Group; Early sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair	Other: Early sensory re-education of the hand with a sensor glove model; Training Group patients were submitted to application of a three-month protocol for early sensory re-education of the hand using the sensor glove model developed by Mendes et al. (2011). Patients also received conventional physical therapy for this type of injury in a specialized hand therapy center in a university hospital. Control Group patients received only conventional physical therapy treatment. No home sensory re-education program was established for any group and the CG patients were not submitted to any protocol for early sensory re-education of the hand.; Other Names: Physical Therapy
No Intervention: Control Group; Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
• Investigators: Principal Investigator: Raquel M Sugano, PhD, University of Sao Paolo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Peripheral nerves/lesions; hands; rehabilitation; fMRI
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: Sensor glove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No