Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03191032
Enrollment
17
Registered
2017-06-19
Start date
2013-03-31
Completion date
2014-10-31
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Nerve Injuries

Keywords

Peripheral nerves/lesions; hands; rehabilitation; fMRI

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.

Interventions

OTHEREarly 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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensory Threshold - Mann Whitney non-parametric testFirst, Third and Sixth month post-operativeSensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative
Tactil Gnosis - Mann Whitney non-parametric testFirst, Third and Sixth month post-operativeTactile 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 testFirst, Third and Sixth month post-operativeSelf-report function was assessed by DASH questionnaire at first, third and sixth month post-operative
Cortical responses - fMRI data analysed by Granger Causality MapThree monthsTraining group subjects were submitted to fMRI exam at third month post-operative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026