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临床试验/NCT01887054
NCT01887054已完成不适用

Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease

Duke University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6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
30
试验地点
2
主要终点
Double Limb Support (DLS)

研究概览

简要总结

This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.

详细描述

This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).

This study will involve 2 study groups:

Group A - training group; Group B - no training group/controls.

Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.

Participation in this study is expected to last 6-8 weeks.

研究设计

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

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

  • Age: greater than 18 years old and without an upper age limit
  • diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
  • Ambulate independently without an assistive device for at least 60 meters
  • Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
  • Willingness and ability to participate in training and complete training diary
  • Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
  • Ability to sign informed consent
  • Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus

排除标准

  • Inability to complete questionnaires
  • Unwillingness to participate in training, complete all questionnaires and training diary
  • Subjects with secondary causes of parkinsonism
  • Significant dementia (MOCA <20)
  • Prior deep brain stimulation (DBS) surgery or pallidotomy
  • Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
  • Subjects cannot start any new medications during the study period.

结局指标

主要结局

Double Limb Support (DLS)

时间窗: 6 weeks

Primary outcome will be the percent of the gait cycle spent in DLS. This will be evaluated using a GaitRite via a continuous walk, with subjects walking an 18-20 meter oval loop three times continuously.

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)

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Freezing of Gait in Parkinson's Disease | 临床试验