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Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve (TEXIGLOVE)

This study has been terminated.
(Technical problem with one of the medical device used for the study.)
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01691443
First received: July 12, 2012
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
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 Intervention
Sensory Deficit
Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • intra-and inter-individual variance in pressure. [ Time Frame: one year ] [ Designated as safety issue: No ]
    pressures are recorded during a test clamping with and without vibration feedback for the entire population


Enrollment: 1
Study Start Date: April 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
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 
Study First Received: July 12, 2012
Last Updated: October 17, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on December 09, 2016