- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847611
Validation of the Dynamometer LABIN (DYNAVAL)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Chu Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Publications and helpful links
General Publications
- Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.
- Harkonen R, Harju R, Alaranta H. Accuracy of the Jamar dynamometer. J Hand Ther. 1993 Oct-Dec;6(4):259-62. doi: 10.1016/s0894-1130(12)80326-7.
- Bautmans I, Mets T. A fatigue resistance test for elderly persons based on grip strength: reliability and comparison with healthy young subjects. Aging Clin Exp Res. 2005 Jun;17(3):217-22. doi: 10.1007/BF03324600.
- Bellace JV, Healy D, Besser MP, Byron T, Hohman L. Validity of the Dexter Evaluation System's Jamar dynamometer attachment for assessment of hand grip strength in a normal population. J Hand Ther. 2000 Jan-Mar;13(1):46-51. doi: 10.1016/s0894-1130(00)80052-6.
- Martin-Ponce E, Hernandez-Betancor I, Gonzalez-Reimers E, Hernandez-Luis R, Martinez-Riera A, Santolaria F. Prognostic value of physical function tests: hand grip strength and six-minute walking test in elderly hospitalized patients. Sci Rep. 2014 Dec 22;4:7530. doi: 10.1038/srep07530.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Healthy Volunteers
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Danone NutriciaCompletedHealthy Elderly | Healthy VolunteersChina
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
Clinical Trials on Dynamometer LABIN
-
University of BrasiliaCompleted
-
Cairo UniversityCompletedArthroscopic Shoulder Surgery | Arthroscopic Bankart Repair | Hand Grip Strength | Rotator Cuff StrengthEgypt
-
University of Mogi das CruzesCompleted
-
Central Park Medical CollegeShalamar Teaching HospitalCompletedPregnancy Related | Hand GraspPakistan
-
Cairo UniversityActive, not recruitingAbdominal Obesity in Young and Middle Aged Adults | Gluteal Muscles Strength and EnduranceEgypt
-
Ayman MohamedUnknown
-
National Yang Ming UniversityFu Jen Catholic UniversityCompleted
-
Selcuk UniversityRecruitingSjogren's SyndromeTurkey
-
Cairo UniversityNot yet recruitingSmartphone Addiction | De Quervain Tenosynovitis
-
Centre Hospitalier Universitaire DijonRecruitingPost-stroke Patient in Acute, Sub-acute Phase or ChronicFrance