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

Not Applicable

Terminated

• Conditions: Sensory Deficit
• Interventions: Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense

• Registration Number: NCT01691443
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Study Start: 2013-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of the glove	pressure sensor and wrist shaker, not marked CE, developped by Texisense	The subject wear the glove for the time of the trial

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble; 🇫🇷 Grenoble, France