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

Peripheral Nerve Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191032
• Other study ID #: Sensor glove
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 19, 2017
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	FAEPA, Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Cortical responses - fMRI data analysed by Granger Causality Map	Training group subjects were submitted to fMRI exam at third month post-operative	Three months