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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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ClinicalTrials.gov Identifier: NCT01691443
Recruitment Status : Terminated (Technical problem with one of the medical device used for the study.)
First Posted : September 24, 2012
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment Phase
Sensory Deficit Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Use of the glove
The subject wear the glove for the time of the trial
Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 (<S3 according Zachary modified Dellon).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691443


Locations
France
Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Denis Corcella, MD University Hospital, Grenoble

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01691443     History of Changes
Other Study ID Numbers: DCIC 11 17
2012-A00457-36 ( Other Identifier: IDRCB )
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016