Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments
研究概览
简要总结
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.
The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.
详细描述
To evaluate the effect of CG on standing static balance in patients with EDS, this study is a pilot study, carried out according to a cross-over scheme of type AB/BA.
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B). Patients will be randomly assigned to 2 groups: the AB or BA sequence will be randomized for each patient.
For each evaluation, a measurement with eyes open and eyes closed will be performed.
A clinical balance assessment by the Berg test will be performed for each of the conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EDS patients over 18 years of age walking around without technical assistance.
- •Patients will need to be diagnosed both during the interview (presence of a family history, hypermobility and joint instability that has been evolving for years) and with a guide for analysis from EDS to AP-HP.
- •Beighton's score must be 5/9 or higher.
- •Free from any other pathology likely to have an impact on the balance.
- •Patient with a CG as part of his or her management of the EDS
- •Sufficient understanding to understand the objectives of the study and give consent.
- •Patient affiliated or benefiting from a social security scheme
- •Allergies to one of the components (Polyamide and Elastane) of the CG
- •Recent compression garments less than 6 months old.
排除标准
- •Patient under guardianship, curators, justice protection.
- •Comorbidity likely to influence balance.
- •Significant pain (assessed by the patient) induced by the use of CG.
- •Any acute event requires the postponement of the assessment to ensure that the patient's progress is in the usual conditions.
- •Any acute pathology having an impact on the musculoskeletal system and/or general condition.
- •Pregnancy/breastfeeding
- •Compression garments over 6 months old.
结局指标
主要结局
Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments
时间窗: 15 minutes
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
Evaluate the variation in the travel speed of the "center of pressure" without compression garments.
时间窗: 30 minutes
Evaluate the variation in the travel speed of the "center of pressure" without compression garments. Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
次要结局
- Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments(30 minutes)