- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659449
Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip (EvICoMaB)
Assessing the Impact of Different Compression of the Hand (Made to Measure Gloves / Compression Bandaging) Versus Free Hand on the Implementation of the Precision Grip
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with burned hands will realise prehension test to explore dexterity of hand when they wear compressive's treatments and with free hands.
Each patient will realise each test with all conditions (free hands/ made to measure gloves/ compressive bandaging).
Running order of test and condition is randomly defined. Each patient realized this tests under the care and devices used at usual care. Realisation of this tests are not influenced by the study. Patient realised this tests during reeducation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Paca
-
Hyeres, Paca, France, 83418
- Leon Berard hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria :
- Patient admitted from Leon Bérard Hospital
- Burn hand with 2nd or 3nd degree depp
- Dominant hand if bilateral's burning
- Patients requiring compression of the hand
- Patient receiving final compression gloves since seven days ± two days weekend
- Patient affiliated to a social security
Exclusion Criteria :
- No burning of the hand
- contraindication for the use of compression
- Incompatible articular balance with achievement tests
- Patients already included in a second study
- Minor patient or pregnant woman
- Presence of cognitive disorder, preventing the achievement of tests
- Guardianship or individual under the protection of a conservator
- Patients not receiving social security
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block test
Time Frame: mesure will be realised three time : 48h - 96h -144 hours after inclusion
|
A rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, wooden cubes are placed in one compartment or the other. The individual move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. The measure will be realised every two days during one week (duration of study after inclusion of patient) after hand's evaluation by the investigator. |
mesure will be realised three time : 48h - 96h -144 hours after inclusion
|
|
Purdue Pegboard test
Time Frame: mesure will be realised three time: 48h - 96h -144 hours after inclusion
|
The Purdue Pegboard Test is a rectangular board with 2 sets of 25 holes running vertically and 4 concave cups at the top. Small metal pegs are placed in the cup on the side being tested, with subjects asked to remove the pegs and place them vertically in the holes as rapidly as possible. The number of pegs placed in 30 seconds is scored. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator |
mesure will be realised three time: 48h - 96h -144 hours after inclusion
|
|
Jamar's Test
Time Frame: mesure will be realised three time :48h - 96h -144 hours after inclusion
|
A Hand Dynamometer is used for testing hand grip strength. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at the hand of the test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator |
mesure will be realised three time :48h - 96h -144 hours after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick DASH test
Time Frame: 24 hours after inclusion
|
This questionnaire asks about your symptoms as well as your ability to perform certain activities. Quick DASH test is realised 1st day after inclusion of patient on EvICoMaB clinical study and one day before realisation of hand's tests (second day of study) . The measure is obtained at end of questionaire |
24 hours after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valerie Chavineau-Mortelette, MedD, Leon Berard hospital
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
Keywords
Other Study ID Numbers
- 2015-A00381-41.V1.2
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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