Burned HandsEvICoMaBNCT02659449
Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip
An observational study of Burned Hands, run by Hôpital Léon Bérard at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burned Hands
- What is being tested?
- made to measure compression gloves, Compression bandaging and Free Hands
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with burned hands
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
Read the 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.
- Conditions
- Burned Hands
- Being tested
- made to measure compression gloves, Compression bandaging, Free Hands
- Keywords
- hands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
made to measure compression glovesDevice
Also called gloves of medical Z laboratory
Patients achieve tests with compression glove
Compression bandagingDevice
Also called Coheban
Patients achieve tests with compression bandaging
Free HandsOther
Patients achieve tests without device
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: mesure will be realised three time : 48h - 96h -144 hours after inclusion
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
Measured: mesure will be realised three time: 48h - 96h -144 hours after inclusion
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
Measured: mesure will be realised three time :48h - 96h -144 hours after inclusion
Secondary outcomes (1)
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
Measured: 24 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start23 Jun 2016
- Primary completion3 Jul 2016
- Study completionDec 2016
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burned HandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Léon Bérard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Chavineau-Mortelette, MedD, Principal investigator, Léon Bérard Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659449
- Sponsor's protocol ID
- 2015-A00381-41.V1.2
- Acronym
- EvICoMaB
- Status last verified
- Jul 2022
- First submitted
- 27 Oct 2015
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02659449
- Acronym / sponsor ID
- EvICoMaB / 2015-A00381-41.V1.2
- Conditions
- Burned Hands
- Keywords
- hands
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hôpital Léon BérardUniversity, hospital or other
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 3 Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with burned hands
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| made to measure compression glovesAlso: gloves of medical Z laboratoryPatients achieve tests with compression glove | Device | – |
| Compression bandagingAlso: CohebanPatients achieve tests with compression bandaging | Device | – |
| Free HandsPatients achieve tests without device | Other | – |
Primary outcome
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.
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
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
1 secondary outcome
Quick DASH test
Time frame: 24 hours after inclusion
Results and safety
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Chavineau-Mortelette, MedD principal investigator
Léon Bérard Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burned Hands, run by Hôpital Léon Bérard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block test (time frame: mesure will be realised three time : 48h - 96h -144 hours after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.