DYNAVAL: Validation of the Dynamometer LABIN

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT02847611
Collaborator
Department Physical Measures (Other)
30
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Dynamometer LABIN
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation of the Dynamometer LABIN
Actual Study Start Date :
Mar 31, 2016
Actual Primary Completion Date :
Jul 8, 2016
Actual Study Completion Date :
Jul 8, 2016

Arms and Interventions

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

Device: Dynamometer LABIN
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

Device: Dynamometer LABIN
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.

Outcome Measures

Primary Outcome Measures

  1. Measure of the strength of prehension (in Kg). [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).

Secondary Outcome Measures

  1. The comfort of the using the dynamometer LABIN [at day 1]

    A note of discomfort on Simple Verbal Scale from 0 to 10 (max.) is attributed by the subject

  2. muscular endurance, estimated by dynamometer LABIN preservation of the strength for the LABIN [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand
  • Department Physical Measures

Investigators

  • Principal Investigator: Emmanuel COUDEYRE, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT02847611
Other Study ID Numbers:
  • CHU-0274
  • 2015-A01732-47
First Posted:
Jul 28, 2016
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Keywords provided by University Hospital, Clermont-Ferrand

Study Results

No Results Posted as of Sep 19, 2019