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

Primary Purpose

Peripheral Nerve Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early sensory re-education of the hand with a sensor glove model
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injuries focused on measuring Peripheral nerves/lesions; hands; rehabilitation; fMRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Training Group

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Sensory Threshold - Mann Whitney non-parametric test
    Sensory Threshold was assessed by esthesiometry at 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
    Self-report function - Mann Whitney non-parametric test
    Self-report function was assessed by DASH questionnaire at 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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2017
    Last Updated
    June 19, 2017
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03191032
    Brief Title
    Early Sensory Re-education of the Hand With a Sensor Glove Model
    Official Title
    Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the 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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Nerve Injuries
    Keywords
    Peripheral nerves/lesions; hands; rehabilitation; fMRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Training Group
    Arm Type
    Experimental
    Arm Description
    Early sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol
    Intervention Type
    Other
    Intervention Name(s)
    Early sensory re-education of the hand with a sensor glove model
    Other Intervention Name(s)
    Physical Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Sensory Threshold - Mann Whitney non-parametric test
    Description
    Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative
    Time Frame
    First, Third and Sixth month post-operative
    Title
    Tactil Gnosis - Mann Whitney non-parametric test
    Description
    Tactile Gnosis was assessed by Two-point discrimination and Shape and Texture Identification Test at first, third and sixth month post-operative
    Time Frame
    First, Third and Sixth month post-operative
    Title
    Self-report function - Mann Whitney non-parametric test
    Description
    Self-report function was assessed by DASH questionnaire at first, third and sixth month post-operative
    Time Frame
    First, Third and Sixth month post-operative
    Title
    Cortical responses - fMRI data analysed by Granger Causality Map
    Description
    Training group subjects were submitted to fMRI exam at third month post-operative
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raquel M Sugano, PhD
    Organizational Affiliation
    University of Sao Paolo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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