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

NCT ID: NCT03191032

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Physical Therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: 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

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marisa de Cassia Registro Fonseca

Collaborator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel M Sugano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paolo

Other Identifiers

Sensor glove

Identifier Type: -

Identifier Source: org_study_id