Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in Box & Blocks Test from baseline
研究概览
简要总结
The aim of the study is to optimise the hand dexterity exercising program in virtual reality (VR) for patients with multiple sclerosis and Parkinson's disease. Little research has been published on this topic, but the preliminary results are promising. Different levels of difficulty of a VR game will be tested. The patients will be assessed using neuropsychological tests of executive functions, visuospatial abilities, mental speed, flexibility and motor speed. Functional ability, coordination and cognitive abilities will also be assessed.
详细描述
Each patient meeting the inclusion criteria will be randomised to one of the four groups (i.e., 10cubes game difficulty level). The patients will perform five exergaming sessions, each session lasting for 1 hour, on five consecutive working days within the period of two weeks. The 10cubes task requires that all 10 cubes are moved within 2 minutes. Each patient will perform the task 5 times in succession with 1-2 minute breaks. The patients will be assessed using the Box & Blocks Test, Frontal Assessment Battery (FAB), Delis-Kaplan Executive Function System (D-KEFS) and Judgment of Line Orientation (JLO) before the first session and after the last session. In addition, the patients will fill in the Intrinsic Motivation Inventory (IMI) after each session. Based on statistical sample size calculations, the study plan is to include 80 patients with Parkinson's disease and 12 patients with multiple sclerosis randomising them separately, so that the groups will be balanced in terms of size and diagnosis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnose of Parkinson's disease or multiple sclerosis;
- •Mini Mental State Examination score above 24;
- •preserved upper limb function;
- •for Parkinson's disease patients Hoehn and Yahr scale score between 2 and 3.
排除标准
- •any communicable disease;
- •severe vision impairment.
结局指标
主要结局
Change in Box & Blocks Test from baseline
时间窗: Assessment at baseline and after two weeks
Standard clinical test to assesses unilateral gross manual dexterity; the minimum possible score is 0, the maximum is 150; higher score indicates better outcome.
Change in Frontal Assessment Battery (FAB) score from baseline
时间窗: Assessment at baseline and after two weeks
Brief neuropsychological test battery to assess executive functions; the minimum possible score is 0, the maximum is 18; higher score indicates better outcome.
Intrinsic Motivation Inventory (IMI) scores
时间窗: Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale
The IMI is a multidimensional measurement instrument for assessing subjective experience of a target activity. The 22-item version that consists of four subscales will be used (scores range from 7 to 49 for one scale and from 5 to 35 for three scales); higher scores indicate better outcome.
次要结局
- Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline(Assessment at baseline and after two weeks)
- Change in Judgment of Line Orientation (JLO)(Assessment at baseline and after two weeks)