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

NCT03191032 | Completed

• 1 other identifier: Sensor glove
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Nerve Injuries

Keywords

Peripheral nerves/lesions; hands; rehabilitation; fMRI

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Training Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol

Interventions

Early sensory re-education of the hand with a sensor glove model OTHER

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.

Also known as: Physical Therapy

Training Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo: collaborator

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Raquel M Sugano, PhD

  University of Sao Paolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 19, 2017
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share