Validation of the Dynamometer LABIN (DYNAVAL)

September 18, 2019 updated by: University Hospital, Clermont-Ferrand

The main objective of this work is to validate the dynamometer LABIN in comparison with the technique of gold-standard reference JAMAR, in a healthy population.

The infringement of the prehension is frequent and impacts on the social and professional quality of life of the patients. There are numerous instruments measuring the strength of prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the maximal strength of the prehension. It is at present Gold Standard for the measure of the strength of prehension. There is for the moment no electronic known instrument exploring the endurance of the strength of prehension during an effort of tightening. This parameter would indeed be interesting for the exploration in geriatrics and in the neuromuscular pathologies.

This study justifies itself by the fact that the dynamometer LABIN should allow the evaluation of the muscular endurance of the strength of hand as complement of the peak of strength

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measure of the strength of prehension with JAMAR and LABIN according to the following protocol:

  • Position: the subject sits comfortably on a chair without armrests, feet put on the ground, the pond at the bottom of the seat, the hips and the knees in 90 ° of flexion, shoulder in adduction and neutral rotation, the elbow bent in 90 °, forearm in neutral position, the wrist between 0 and 30 ° of extension and between 0 and 15 ° of slope ulnaire. The dynamometer is vertically presented and in front of the forearm to maintain the standardized positions.
  • Test: regulation of the zero by making a vacuous acquisition during 5 seconds. The order "Jamar then Labin" or Labin then Jamar is chosen by randomization. The operator encourages the subject to every test. The subject does not see the curve displaying.
  • Test: 3 clampings of a handle of a dynamometer LABIN by the right hand during 5 seconds, with a break of 30 seconds between the tests. After 2 minutes of break the subjects make 3 clampings with a left hand. After that , the same session is realized with the dynamometer JAMAR

The order "Jamar then Labin" or Labin then Jamar is chosen by randomization. The operator encourages the subject to every test. The subject does not see the curve displaying.

Total duration of participation in the study for the patient: 30 minutes

Main analysis: the calculation of the coefficient of correlation (Pearson or Spearman with regard to the statistical distribution), coefficient of linen concordance and the coefficient of intra-classy correlation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : > 20 years and <60 years
  • Professionally active
  • Right-handed(right-wing) or left-handed person
  • Volunteer
  • Subjects have given its consent in writing to participate in the study

Exclusion Criteria:

  • Subjects with a trauma or surgery of the upper limb
  • Subjects with a diabetes
  • Subjects with a dysthyroïdie
  • Subjects with a neurological disease
  • Subjects with a syndrome canalaire of the upper limb
  • Subjects with a cutaneous disorders(confusions) of the cognitive upper

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jamar then Labin
The order of the using of the dynamometers "Jamar then Labin" or "Labin then Jamar" is chosen by randomization
LABIN is a prototype of dynamometer containing a handle of metal strength, connected with a sensor of pressure registering(recording) the applied strength and transmitting the data in a computer showing an IT curve of the strength according to time.
Experimental: Labin then Jamar
The order of the using of the dynamometers "Jamar then Labin" or "Labin then Jamar" is chosen by randomization
LABIN is a prototype of dynamometer containing a handle of metal strength, connected with a sensor of pressure registering(recording) the applied strength and transmitting the data in a computer showing an IT curve of the strength according to time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the strength of prehension (in Kg).
Time Frame: at day 1
measure of the strength of prehension in kilogram by using of the JAMAR ( hydraulic dynamometer), and the LABIN (electronic dynamometer provided with a sensor of pressure).
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comfort of the using the dynamometer LABIN
Time Frame: at day 1
A note of discomfort on Simple Verbal Scale from 0 to 10 (max.) is attributed by the subject
at day 1
muscular endurance, estimated by dynamometer LABIN preservation of the strength for the LABIN
Time Frame: at day 1
Change from baselin in measure muscular endurance (The calculation of the horizontal length under the graphic curve which will be exploited by the colleagues of the IUT)
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2016

Primary Completion (Actual)

July 8, 2016

Study Completion (Actual)

July 8, 2016

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHU-0274
  • 2015-A01732-47 (Other Identifier: 2015-A01732-47)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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