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

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.

Study Overview

• Status: Terminated
• Conditions: Sensory Deficit
• Intervention / Treatment: Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-and inter-individual variance in pressure.	pressures are recorded during a test clamping with and without vibration feedback for the entire population	one year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Denis Corcella, MD, University Hospital, Grenoble

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DCIC 11 17; 2012-A00457-36 (Other Identifier: IDRCB)