Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- gait velocity
研究概览
简要总结
Efficient gait requires effective postural control, both static and dynamic. Hence, postural disorders may affect gait. Yet, very little is known about the specific effects of focal postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients' mobility.
The present research therefore aims at analyzing gait characteristics in patients presenting with these conditions in order to document possible gait alterations.
In addition, the investigators will explore the effect of botulinum toxin treatment, which the most frequently used therapeutic option, on the patients' gait characteristics. Indeed, while the treatment improves both dystonia and pain, and therefore quality of life, its influence on gait is presently unknown. the investigators aim at filling this knowledge gap
详细描述
This is a pilot monocentric, non-randomized, controlled study. The total duration of the project is 24 months. For each patient, the total duration of the study will be one month.
The primary goal is to study gait parameters in patients with focal dystonia (CD and BS) before and after botulinum toxin treatment.
The secondary goal is to study interactions between dystonia severity and gait disorders, if gait disorders are objectified. The investigators will also examine whether botulinum toxin treatment affects gait parameters.
The main dependent variable regarding gait analysis will be gait velocity, as it is the most relevant functional variable for the patients. Gait velocity will be measured on the ground using the 10 Meter Walk Test (10MWT). Gait velocity will thereafter be adjusted to the treadmill to be the most comfortable. Spatial and temporal gait parameters will also be analyzed, namely: step frequency, step length, step length variability, gait asymmetry, and side with the shortest step length.
To examine the influence of dystonia severity on gait parameters, the investigators will examine possible links between the gait parameters and dystonia severity as reflected by the global scores of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) for cervical dystonia and the Jankovic Rating Scale (JRS) for blepharospasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •speaking French, in the ability to understand clinical tests and explorations,
- •in ability to move to the CHU Grenoble Alpes
- •Diagnosis of cervical dystonia or isolated Blepharospasm,
- •Absence of neurological or psychiatric disorders,
- •Affiliation to a health insurance,
- •Signed consent fo the subject.
排除标准
- •Pregnant women (positive pregnancy test), parturient or breastfeeding
- •Cervical dystonia or Blepharospasm of secondary origin
- •subjects having benefited from deep brain stimulation,
- •History of other pathologies that may lead to walking disorders, inability to walk without technical assistance, inability to walk for more than 10 minutes,
- •Subjects receiving botulinum toxin treatment for another cause.
- •Prohibited treatments and procedures:
- •Antecedent of pathologies that may cause walking disorders
- •Simultaneous participation in another Interventional study
- •Subject in time of exclusion from another study
- •Subject under guardianship or having curators (major protected)
- •Subject under administrative or judicial supervision
- •Subject not able to be contacted in case of emergency
研究组 & 干预措施
Cervical Dystonia (CD)
Patients with cervical dystonia
干预措施: Treadmill (Other)
Cervical Dystonia (CD)
Patients with cervical dystonia
干预措施: Botulinum Toxin injection (Drug)
Cervical Dystonia (CD)
Patients with cervical dystonia
干预措施: Severity scale of the disease (Diagnostic Test)
Healthy Control CD
CD age- and sex-matched healthy control subjects
干预措施: Treadmill (Other)
Blepharospasm (BS)
Patients with blepharospasm
干预措施: Treadmill (Other)
Blepharospasm (BS)
Patients with blepharospasm
干预措施: Botulinum Toxin injection (Drug)
Blepharospasm (BS)
Patients with blepharospasm
干预措施: Severity scale of the disease (Diagnostic Test)
Healthy Control BS
BS age- and sex-matched healthy control subjects
干预措施: Treadmill (Other)
结局指标
主要结局
gait velocity
时间窗: 5 minutes
comfortable gait velocity on the treadmill
次要结局
- step length variability(5 minutes)
- step frequency(5 minutes)
- step length(5 minutes)
- step length asymmetry(5 minutes)
- shortest step side(5 minutes)