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临床试验/NCT02977377
NCT02977377已完成不适用

Ataksili Hastalarda Tüm Vücut Vibrasyonunun Postüral Kontrol Üzerine Etkileri

Hacettepe University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Sensory organization test of Computerized Dynamic Posturography (CDP)

研究概览

简要总结

To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia

详细描述

Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out period, patients assigned other therapy period. All assessments will be repeated before and after each therapy period. Exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

The evaluation parameters consists of demographic information, Computerized Dynamic Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg Balance Scale, Barthel Index and Goal Assessment Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ataxia
  • Ataxic patients who are able to walk 25 m independently

排除标准

  • Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
  • Clinical diagnosis of cognitive impairment

研究组 & 干预措施

Whole body vibration/ Exercise

Active Comparator

Exercise therapy and whole body vibration will be applied together for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest) before exercises. After 1 week washout period, exercise program will apply for 8 weeks.

干预措施: Exercise therapy (Other)

Whole body vibration/ Exercise

Active Comparator

Exercise therapy and whole body vibration will be applied together for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest) before exercises. After 1 week washout period, exercise program will apply for 8 weeks.

干预措施: Whole body vibration (Other)

Exercise/ Whole body vibration

Active Comparator

Exercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks.

干预措施: Exercise therapy (Other)

Exercise/ Whole body vibration

Active Comparator

Exercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks.

干预措施: Whole body vibration (Other)

结局指标

主要结局

Sensory organization test of Computerized Dynamic Posturography (CDP)

时间窗: change from baseline in sensory component of postural control at 8 weeks

Computerized Dynamic Posturography (CDP) is a unique assessment technique used to objectively quantify and differentiate among the wide variety of possible sensory, motor, and central adaptive impairments to balance control. CDP has severeal test protocols; a Sensory Organization Test (SOT), Limits of Stability Test (LOS), a Motor Control Test (MCT) and an Adaptation Test (ADT) used in the study. Sensory organization test (SOT) evaluates the relative contributions of vestibular, visual and somatosensory systems to balance maintenance when somatosensory information regarding the orientation of the body's centre of gravity is systematically manipulated.

次要结局

  • International Cooperative Ataxia Rating Scale(change from baseline in severity of ataxic symptoms at 8 weeks.)
  • Berg Balance Scale(change from baseline in balance performance at 8 weeks.)
  • Barthel Index(change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.)
  • Limits of stability test of Computerized Dynamic Posturography (CDP)(change from baseline in dynamic balance component of postural control at 8 weeks)
  • Motor Control Test of Computerized Dynamic Posturography (CDP)(change from baseline in automatic motor system component of postural control at 8 weeks)
  • Adaptation Test of Computerized Dynamic Posturography (CDP)(change from baseline in postural sway in changes of support surface component of postural control at 8 weeks)
  • Trunk Impairment Scale(change from baseline in impairment of trunk at 8 weeks.)
  • Goal Assessment Scale(change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ender AYVAT

Research Assistant

Hacettepe University

研究点 (2)

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