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临床试验/NCT03515746
NCT03515746已完成不适用

3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease

University Rehabilitation Institute, Republic of Slovenia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月11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
20
试验地点
2
主要终点
UDPRS III Motor

研究概览

简要总结

A pilot study with the "10cubes" for small and precise movements and training in the virtual environment will be carried out. We will recruit at least 20 persons with Parkinson's disease to participate in the study. Such activities can increase participation, slow down the progress of the disease and contribute to the functional improvements of the hand that lead to the increased quality of life. The movement of the hand will be assessed with a small 3D camera, also suitable for the estimation of kinematic parameters. Participants will be randomized into 2 groups; one group using an LCD screen and the other using 3D goggles (Oculus Rift CV1) enabling them to carry out the task in virtual environment. Both groups will take 10 training sessions within 2 weeks. Their task will be collecting 10 virtual cubes one-by-one and putting them in the virtual treasure box. Clinical tests (Box and Blocks Test and motor part of the UPDRS) will be carried out in the clinical settings prior and after the training sessions. We hypothesise that the different feedback equipment may provide different results.

详细描述

The participants will practise grab and grasp in virtual environment (VE), either on a laptop computer or using 3D goggles. They will sit in a comfortable chair, with a small camera tracking the hand and finger movements of their affected (dominant, in case of both hands affected) hand. The participant will grab any of the virtual cubes lying around the VE and put it in the treasure box. When the cube falls into the treasure box it disappears and the participant scores, one by one until the 10th cube or 120s of time elapse. The cubes will be randomly spread in the VE and will all have the same virtual size, weight and bouncing factor, but different colour. If the participant is left-handed, the treasure box will be mirrored to the right side. If the cube is pushed into the floor, it disappears without a score and is lost. Each participant will take 10 consecutive training sessions in 2 weeks, each session lasting for 30min. Within a session, the participant will take 5 trials, with breaks of 1-2 min between them.

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

入选标准

  • Parkinson's disease diagnosis
  • minor problems with daily activities and upper extremities
  • Hoehn and Yahr Scale level 2-3

排除标准

  • insufficient cognitive and motor abilities to carry out the exergaming task

结局指标

主要结局

UDPRS III Motor

时间窗: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session

Unified Parkinson's Disease Rating Scale Motor Function Part - difference score

BBT

时间窗: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session

Box \& Blocks Test - difference score

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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