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Completed

NCT Number: NCT03191032

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Physical Therapy

Primary outcomes

  1. Sensory Threshold - Mann Whitney non-parametric test

    Time frame: First, Third and Sixth month post-operative

    Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative

  2. Tactil Gnosis - Mann Whitney non-parametric test

    Time frame: 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

  3. Self-report function - Mann Whitney non-parametric test

    Time frame: First, Third and Sixth month post-operative

    Self-report function was assessed by DASH questionnaire at first, third and sixth month post-operative

  4. Cortical responses - fMRI data analysed by Granger Causality Map

    Time frame: Three months

    Training group subjects were submitted to fMRI exam at third month post-operative

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2017
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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