跳至主要内容
临床试验/NCT02464852
NCT02464852已完成不适用

Assessment of the Effects of Sheffield Support Snood in MND Patients

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
electrical activity produced by the muscle measured by the EMG system

研究概览

简要总结

The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood.

详细描述

Motor Neurone Disease (MND) is neurodegenerative disorder that leads to progressive weakness of limb, bulbar and respiratory muscles. The most common form of the disease is the Amyotrophic Lateral Sclerosis (ALS). Severe weakness of the neck extensor muscles is common in patients with ALS. Those patients are advised to wear a cervical collar, to improve their neck posture and social interaction. However the main limit of commercially available collars is that they are designed to immobilize the neck, which makes them uncomfortable and strenuous to wear for long time. The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood. The assessment will be performed through the use of inertial sensors since they allow the measurement to be performed in real life settings (clinics/home) with reduced discomfort to the patient. Subjects will be asked to perform a series of active head movements (flexion, extension, axial rotation, lateral bending) with and without the collar and the range of movement measured in the two cases will be used to assess the support offered by the collar. Since in MND patients difficulty in perform active head movements is due to a severe weakness of the extensor muscles, with or without involvement of the neck flexors, this study will also investigate the activation of these muscles while the subject is performing the active head movements. A wireless surface electromyographic system (sEMG) will be used to this purpose. Patients able to perform a series of activities of daily living (ADL, ie: drinking, eating, washing hands) will be asked to perform the tasks both with and without the collar. The support perceived by the subjects while they are performing the ADL will be evaluated through a questionnaire specifically developed for this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical status consistent with MND
  • Capability to understand instructions
  • Capability to perform testing procedures
  • Ability to give informed consent

排除标准

  • Presence of any inflammatory or other disease involving joint or muscle pathology that might affects testing results
  • Unable to give informed consent

结局指标

主要结局

electrical activity produced by the muscle measured by the EMG system

时间窗: while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes

Description of the support perceived. It will be evaluated through a questionnaire which will include a series of sentences that describe the support offered by the collar. The subjects will be asked to state how much they agree with those sentences.

时间窗: after the subject has performed the head movements (Extension, flexion, axial rotation and lateral bending). Answer the questionnaire will take approximately 10 minutes

angular velocity and acceleration measured by the inertial sensors

时间窗: while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验