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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT01691443 |
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Date of registration:
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12/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve
TEXIGLOVE |
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Scientific title:
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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. |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01691443 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Denis Corcella, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 (
Exclusion Criteria:
- 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
- person hospitalized without their consent
- person under legal protection
- person hospitalized for psychiatric care
- pregnant and parturient women
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sensory Deficit
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Intervention(s)
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Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense
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Primary Outcome(s)
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intra-and inter-individual variance in pressure.
[Time Frame: one year]
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Secondary ID(s)
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2012-A00457-36
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DCIC 11 17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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