Peripheral Nerve InjuriesNCT03191032
Early Sensory Re-education of the Hand With a Sensor Glove Model
A study testing Early sensory re-education of the hand with a sensor glove model in people with Peripheral Nerve Injuries, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Early sensory re-education of the hand with a sensor glove model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired
Who cannot join
- Neurological diseases
- Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
- Extensive traumas in the upper limbs
About this study
Official title: Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction
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
- Being tested
- Early sensory re-education of the hand with a sensor glove model
- Keywords
- Peripheral nerves/lesions; hands; rehabilitation; fMRI
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early sensory re-education of the hand with a sensor glove modelOther
Also called Physical Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Early sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair Receives: Other: Early sensory re-education of the hand with a sensor glove model |
| Control Group | No intervention | Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Threshold - Mann Whitney non-parametric test
Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative
Measured: 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
Measured: 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
Measured: 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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startMar 2013
- Primary completionMar 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Marisa de Cassia Registro Fonseca, University of Sao Paulo
- Investigators
- Raquel M Sugano, PhD, Principal investigator, University of Sao Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191032
- Sponsor's protocol ID
- Sensor glove
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction
- ClinicalTrials.gov ID
- NCT03191032
- Acronym / sponsor ID
- Sensor glove
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Peripheral nerves/lesions; hands; rehabilitation; fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- 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
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Early sensory re-education of the hand with a sensor glove modelEarly sensory re-education of the hand protocol with a sensor glove model, after a median and/or ulnar nerve injury repair |
| Control Group | No intervention | –Conventional rehabilitation for peripheral nerve injuries if the hand, without application of any kind of early sensory re-education protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired
Key exclusion criteria (3 listed)
- Neurological diseases
- Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
- Extensive traumas in the upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early sensory re-education of the hand with a sensor glove modelAlso: Physical TherapyTraining 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. | Other | Training Group |
Primary outcome
Sensory Threshold - Mann Whitney non-parametric test
Time frame: First, Third and Sixth month post-operative
Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative
Tactil Gnosis - Mann Whitney non-parametric test
Time frame: First, Third and Sixth month post-operative
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
Time frame: First, Third and Sixth month post-operative
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
Time frame: Three months
Training group subjects were submitted to fMRI exam at third month post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel M Sugano, PhD principal investigator
University of Sao Paolo
Questions about this trial
What is this clinical trial studying?
A study testing Early sensory re-education of the hand with a sensor glove model in people with Peripheral Nerve Injuries, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Threshold - Mann Whitney non-parametric test (time frame: First, Third and Sixth month post-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.