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临床试验/NCT03278093
NCT03278093Unknown不适用

The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy

St George's, University of London1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年10月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Posturography

研究概览

简要总结

A cross-sectional study which will look at the effects of AFO's and vibrating insoles on balance performance in people with CMT disease.

详细描述

Balance impairments and falls are more common in people who have Charcot Marie Tooth disease (CMT) than in people without the condition. CMT is a condition which affects the nerves causing a variety of symptoms including sensation impairments and weakness. The impairments are usually most evident in the feet and hands, but they can progress very slowly moving closer to the trunk. Ankle Foot Orthoses (AFO's) are often prescribed to help with walking and daily function. So far the effects of AFO's on standing balance in people who have CMT have not been looked at. Insoles are also often prescribed to realign foot deformity and reduce pain. Insoles which give a vibratory input have had a positive impact on walking in older people but have not been looked at in balance and in CMT. Insoles which give a vibration feedback to the sole of the foot when worn have been designed. This study will look at whether the use of AFO's and the vibratory insoles have an effect on standing balance in people with CMT or related peripheral neuropathy. Balance measurements will be taken in a single session comparing a variety of postures. Patients will be recruited from neurology outpatient clinics at the National Hospital of Neurology and Neurosurgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Clinical or genetically confirmed diagnosis of CMT or related peripheral neuropathy
  • Mixed sensory and motor presentation
  • Over 18 years
  • Able to stand unsupported for five minutes
  • Able to walk for 50m with or without a walking stick or orthotic devices

排除标准

  • Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, epilepsy, movement disorders), or major comorbidities (e.g. vestibular dysfunction, use of medication which may affect balance, cognitive impairment, presence of medical conditions in which exercise training may be detrimental).
  • Presence of peripheral neuropathy caused by a condition other than CMT.
  • Limb surgery during the six months prior to screening (or planned before final assessment).
  • Women of child-bearing age if they are pregnant, planning a pregnancy during their time in the study or in the 12 weeks following giving birth. This is due to the effects of pregnancy on balance.

结局指标

主要结局

Posturography

时间窗: 30 second caputer in a variety of conditions

CODA motion movement analysis for postural sway Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.

force measures

时间窗: 30 second caputer in a variety of conditions

AMTI forceplate for centre of pressure . Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.

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 (1)

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