Sensory DeficitTEXIGLOVENCT01691443
Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve
A study testing pressure sensor and wrist shaker, not marked CE, developped by Texisense in people with Sensory Deficit, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Deficit
- What is being tested?
- pressure sensor and wrist shaker, not marked CE, developped by Texisense
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Mar 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- person between 18 and 45 years old
- affiliation to the french social security system or equivalent
- person signed a consent to participate
- for the patient group: person with post-traumatic sensory deficit in the territory of the right median nerve above the wrist (<S3 according Zachary modified Dellon).
Who cannot join
- person with a cognitive pathology incompatible with the use of the device, understanding and implementation of the protocol
- person with a concomitant nerve injury of any other nerve territory,
- person with pain or stiffness inconsistent with the achievement tests
- person with an allergy to any component of the device: polyamide, cotton, nickel, textile glue, rubber, plastic or latex,
- person with an infectious disease or dermatology of the right hand
- person deprived of freedom by judicial or administrative decision
Show all 10Show fewer
- person hospitalized without their consent
- person under legal protection
- person hospitalized for psychiatric care
- pregnant and parturient women
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble
Grenoble, 38043
About this study
Official title: Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.
The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.
- Conditions
- Sensory Deficit
- Being tested
- pressure sensor and wrist shaker, not marked CE, developped by Texisense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure sensor and wrist shaker, not marked CE, developped by TexisenseProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Use of the glove | Experimental | The subject wear the glove for the time of the trial Receives: Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-and inter-individual variance in pressure.
pressures are recorded during a test clamping with and without vibration feedback for the entire population
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Technical problem with one of the medical device used for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory DeficitStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Denis Corcella, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691443
- Sponsor's protocol ID
- DCIC 11 17
- Other IDs
- 2012-A00457-36
- Acronym
- TEXIGLOVE
- Status last verified
- Oct 2016
- First submitted
- 12 Jul 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.
- ClinicalTrials.gov ID
- NCT01691443
- Acronym / sponsor ID
- TEXIGLOVE / DCIC 11 17
- Conditions
- Sensory Deficit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical problem with one of the medical device used for the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Sep 2012 (estimated)
- 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 objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of the glove | Experimental | Procedure: pressure sensor and wrist shaker, not marked CE, developped by TexisenseThe subject wear the glove for the time of the trial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- person between 18 and 45 years old
- affiliation to the french social security system or equivalent
- person signed a consent to participate
- for the patient group: person with post-traumatic sensory deficit in the territory of the right median nerve above the wrist (<S3 according Zachary modified Dellon).
Key exclusion criteria (10 listed)
- person with a cognitive pathology incompatible with the use of the device, understanding and implementation of the protocol
- person with a concomitant nerve injury of any other nerve territory,
- person with pain or stiffness inconsistent with the achievement tests
- person with an allergy to any component of the device: polyamide, cotton, nickel, textile glue, rubber, plastic or latex,
- person with an infectious disease or dermatology of the right hand
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 |
|---|---|---|
| pressure sensor and wrist shaker, not marked CE, developped by Texisense | Procedure or surgery | Use of the glove |
Primary outcome
intra-and inter-individual variance in pressure.
Time frame: one year
pressures are recorded during a test clamping with and without vibration feedback for the entire population
Results and safety
The study was stopped early (reason given: Technical problem with one of the medical device used for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults
Intrinsic Capacity, Frailty
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.
Denis Corcella, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure sensor and wrist shaker, not marked CE, developped by Texisense in people with Sensory Deficit, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Technical problem with one of the medical device used for the study.). Results are not available in the source record.
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?
intra-and inter-individual variance in pressure. (time frame: one year). 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 18 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.