NCT01691443

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

July 12, 2012

Last Update Submit

October 17, 2016

Conditions

Sensory Deficit

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Use of the glove

EXPERIMENTAL

The subject wear the glove for the time of the trial

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

Interventions

pressure sensor and wrist shaker, not marked CE, developped by TexisensePROCEDURE
Use of the glove

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble

Grenoble, 38043, France

Location

Related Links

Study Officials

  • Denis Corcella, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 12, 2012

First Posted

September 24, 2012

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

FR(1)