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临床试验/NCT03607058
NCT03607058已完成不适用

Ataksik Hastalarda Oyun Temelli Egzersiz Eğitiminin Denge ve Postural Kontrol Üzerine Etkisi

Hacettepe University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Limits of Stability Test of Neurocom Balance Master (Static Posturography)

研究概览

简要总结

This study was planned to investigate the effects of exercise training based on Microsoft Kinect application on balance and postural control in ataxic patients.

详细描述

Patients who meet the inclusion criteria will be divided into two groups randomly: 'Kinect and exercise training' and 'exercise training'. The assessments will be made by a blind investigator four times, before and after the implementation of both protocols. The evaluations will take approximately 1 hour. The demographic information of the cases will be recorded. Designed as cross over study, two treatment protocols will be used in this study. The first protocol will be Xbox Kinect application plus exercise program, the second protocol will be only exercise program. At the beginning of the study, 2 groups will be allocated (Group A and Group B) randomly. For group A, the Xbox Kinect application plus exercise program will be applied for the first 8 weeks. For group B, only exercise program will be applied therapy first 8 weeks. All assessments will be repeated before and after each therapy period. Exercise program will consist of selected balance, coordination and walking exercises according to the individual needs of patients. After 10 weeks washout period, patients will be included in the other group. All patients will take the treatment 1-hour, 3 days in a week for 8 weeks.

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
Double (Investigator, 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
  • Ataxic patients who had a Mini Mental Test Score of 24 points and over;

排除标准

  • Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
  • Clinical diagnosis of cognitive impairment
  • Patients who have fallen at least once in the last 6 months
  • Patients who had Berg Balance Scale score of 40 points and below

结局指标

主要结局

Limits of Stability Test of Neurocom Balance Master (Static Posturography)

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

Limits of stability test (LOS) assesses dynamic balance during the performance of specific tasks with visual feedback. It quantifies objectively the maximum distance a person can lean in a given direction without losing balance, stepping or reaching for assistance

次要结局

  • Dynamic Gait Index (DGI)(change from baseline in balance, fall risk and gait at 8 weeks)
  • International Cooperative Ataxia Rating Scale(change from baseline in severity of ataxic symptoms at 8 weeks)
  • 10 meter Walk Test (10mWT)(change from baseline in gait speed at 8 weeks)
  • Berg Balance Scale (BBS)(change from baseline in balance performance at 8 weeks)
  • Rhythmic Weight Shift (RWS) of Neurocom Balance Master (Static Posturography)(change from baseline in directional control and movement velocity while move the center of gravity at 8 weeks)
  • Trunk Impairment Scale(change from baseline in impairment of trunk at 8 weeks)
  • Timed Up and Go test (TUG)(change from baseline in falling risk at 8 weeks)
  • Functional Reach Test (FRT)(change from baseline in dynamic balance at 8 weeks)
  • Walk Across (WA) of Neurocom Balance Master (Static Posturography)(change from baseline in gait characteristics at 8 weeks)
  • Weight Bearing Squat (WBS) of Neurocom Balance Master (Static Posturography)(change from baseline in weight bearing at 8 weeks)
  • Unilateral Stance Test (US) of Neurocom Balance Master (Static Posturography)(change from baseline in postural sway velocity at 8 weeks)

研究者

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

ÖZGE ONURSAL KILINÇ

Research Assistant

Hacettepe University

研究点 (2)

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