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
About this trial
This is an interventional treatment trial for Peripheral Nerve Injuries focused on measuring Peripheral nerves/lesions; hands; rehabilitation; fMRI
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
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
NCT ID
NCT03191032
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
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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