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Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip (EvICoMaB)

2022年7月22日 更新者:Hôpital Léon Bérard

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)

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

3

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Paca
      • Hyeres、Paca、法国、83418
        • Leon Berard hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with burned hands

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:案例交叉
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Box and Block test
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Quick DASH test
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Valerie Chavineau-Mortelette, MedD、Leon Berard hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年6月23日

初级完成 (实际的)

2016年7月3日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2015年10月27日

首先提交符合 QC 标准的

2016年1月15日

首次发布 (估计)

2016年1月20日

研究记录更新

最后更新发布 (实际的)

2022年7月26日

上次提交的符合 QC 标准的更新

2022年7月22日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2015-A00381-41.V1.2

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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