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

Sensory Deficit Clinical Trial

— TEXIGLOVE  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01691443
• Other study ID #: DCIC 11 17
• Secondary ID: 2012-A00457-36
• Status: Terminated
• Phase: N/A
• First received: July 12, 2012
• Last updated: October 17, 2016
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Sensory Deficit

Intervention

Procedure:
• pressure sensor and wrist shaker, not marked CE, developped by Texisense

Locations

Country	Name	City	State
France	Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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