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临床试验/NCT03459014
NCT03459014已完成不适用

The Use of Immersive Virtual Reality During Robot-assisted Walking in Healthy Adults - Effect of Changing the Optic Flow Speed in Two Different Virtual Environments on Active Participation During Robot-assisted Walking.

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Interaction torques right knee

研究概览

简要总结

The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed in 2 different virtual environments (VE) on active participation in healthy participants during virtual reality (VR) - enhanced robot-assisted gait(RAG).

The second aim is to investigate the effect of two different VEs on active participation during RAG.

详细描述

STUDY DESIGN: an experimental, 2-group, single-center trial will be conducted in which healthy participants will perform one VR-enhanced RAG session in which 3 different OF speeds will be presented in a random order: 1) walking with slow OF speed, 2) walking with matched OF speed, and 3) walking with fast OF speed. The VE will be different for both groups. The experimental group will have a stimulus rich VE that represents a park where subjects will walk through. This VE will be more interactive by allowing other avatars or animals to walk through the VE. The control group will have a stimulus poor VE that represents an endless hallway. Since the subjects will walk alone in the hallway for the entire time, this VE will be less interactive.

PATIENT RECRUITMENT: we aim to recruit 28 healthy participants, divided equally into two groups. In case subjects drop out, additional participants will be tested till 14 participants in each group completed all conditions.

PROCEDURE: Participants will be tested during one VR-enhanced RAG session at the rehabilitation center TrainM (Antwerp). Prior to the start of the experiment, surface electrodes will be placed bilateral on the Mm. rectus femoris and Mm. biceps femoris to measure muscle activity. Electrode placement will follow as closely as possible the guidelines of SENIAM. The skin underlying the electrode will be shaved and cleaned to improve electrode-skin contact and reduce impedance. At the start of the session, participants will be habituated to walking in the Lokomat without the VR. During this habituation trial, the appropriate settings to walk comfortable in the exoskeleton will be determined. To make sure all participants will walk comfortable in the Lokomat, subjects will be provided with a body weight support (BWS) of 30%. Guidance Force (GF) will be set on 80% for all participants. With lower levels of GF, the biofeedback values will show smaller changes and can become negligible. Lastly, the walking speed (WS) will be set at 2.8 km/h for all participants. Preparing and installing the participant and determining the appropriate Lokomat settings will take no longer than 20 minutes. When the Lokomat settings are defined, the Lokomat will be stopped for a moment so that the VR can be added. Participants will put on the head-mounted display (HMD) and will start walking again for one minute while watching the VE scene expanding at a speed matching their walking speed to get used to the VR. After the habituation trial, participants will walk in the Lokomat with the three different OF speeds that will be presented in a random order for 7 minutes each:

  1. slower OF: 0.5 times the individual's WS,
  2. matched OF: same as the individual's WS,
  3. faster OF: 2 times the individual's WS.

In order to normalize the registered EMG signals, the maximum voluntary isometric contraction (MVIC) test will be used. Each subject carries out the MVIC test 3 times for each muscle. Subjects must reach their maximum strength as quickly as possible and must keep it for 6 seconds. Subjects will perform the MVIC test in the following testing positions: prone with the knees in 30° of flexion (Mm. biceps femoris); seated with the knees in 60°of flexion, and the hips in 90° of flexion (Mm. rectus femoris). The average of the three tests will be taken for each muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy persons ≥ 55 years of age,
  • Normal or corrected-to-normal vision with glasses or contact lenses,
  • No locomotion impairments,
  • A maximal body weight of 135 kg,
  • A maximal body height of 200 cm

排除标准

  • Skin lesions that cannot be protected appropriately,
  • Significant lower extremity injuries during the last two years that might affect their gait,
  • Any type of vestibular/visual deficiency

研究组 & 干预措施

Stimulus rich VE

Experimental

Participants will be tested during 1 RAG session in the Lokomat. Participants in the experimental group will walk in a stimulus rich VE such as walking in a park.

干预措施: Stimulus rich VE (Other)

Stimulus poor VE

Active Comparator

Participants will be tested during 1 RAG session in the Lokomat. Participants in the control group will walk in a stimulus poor VE, such as walking through an endless hallway.

干预措施: Stimulus poor VE (Other)

结局指标

主要结局

Interaction torques right knee

时间窗: Every minute of the 21-minute session.

Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Interaction torques left hip

时间窗: Every minute of the 21-minute session.

Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Range of motion right knee

时间窗: Every minute of the 21-minute session.

Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Interaction torques left knee

时间窗: Every minute of the 21-minute session.

Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Range of motion left hip

时间窗: Every minute of the 21-minute session.

Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Range of motion left knee

时间窗: Every minute of the 21-minute session.

Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Muscle activity (EMG)

时间窗: Every minute of the 21-minute session.

Muscle activity will be measured continuously during the 21 minutes of testing. Average muscle activity (%MVIC) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Interaction torques right hip

时间窗: Every minute of the 21-minute session.

Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

Range of motion right hip

时间窗: Every minute of the 21-minute session.

Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

次要结局

未报告次要终点

研究者

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

Emma De Keersmaecker

Doctoral Researcher

Vrije Universiteit Brussel

研究点 (2)

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