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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02659449
Other study ID # 2015-A00381-41.V1.2
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 23, 2016
Est. completion date December 2016

Study information

Verified date July 2022
Source Hôpital Léon Bérard
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date December 2016
Est. primary completion date July 3, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
made to measure compression gloves
Patients achieve tests with compression glove
Compression bandaging
Patients achieve tests with compression bandaging
Other:
Free Hands
Patients achieve tests without device

Locations

Country Name City State
France Leon Berard hospital Hyeres Paca

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Léon Bérard

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Box and Block test 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
Primary Purdue Pegboard test 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
Primary Jamar's Test 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 Quick DASH test 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