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临床试验/NCT04562662
NCT04562662已完成不适用

Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study

Japan Society of Clinical Research2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in Timed up and go test

研究概览

简要总结

The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.

详细描述

The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with >90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.

First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 * maximum reaching distance, 0.9 * (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.

The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 110 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with physical and/or cognitive dysfunctions
  • Agreed to the participation of this study with written informed consent by themselves or guardians

排除标准

  • 1. Inappropriate candidates at attending physician's discretion

结局指标

主要结局

Change in Timed up and go test

时间窗: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. Shorter score means a better outcome. The minimum value could be 5 seconds or less, and the maximum value could be infinity (cannot complete the test).

Change in Trail Making Test

时间窗: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. Shorter score means a better outcome. The minimum value could be 15 seconds or less, and the maximum value could be infinity or be defined as 300 seconds when patients cannot complete the test.

次要结局

  • Changes in Mini Mental State Examination(baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention)
  • Changes in Functional Independence Measure(baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention)
  • Changes in Berg balance scale(baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention)
  • Changes in Self Rating Depression Scale(baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention)

研究者

发起方
Japan Society of Clinical Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Masahiko Hara

Principal Investigator

Japan Society of Clinical Research

研究点 (2)

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