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临床试验/NCT03898375
NCT03898375终止不适用

VR-enhanced Walking in People Post-stroke: the Effect of Changing the Optic Flow Speed During Treadmill Walking on the Gait Pattern

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Muscle activity (EMG)

研究概览

简要总结

The aim of this study is to investigate the onset, magnitude and duration of the effect of manipulating the optic flow on the gait pattern during Virtual Reality (VR)-enhanced treadmill walking compared to treadmill walking without VR in people post-stroke.

详细描述

STUDY DESIGN: An experimental 1-group, single-centre trial will be conducted in which people post-stroke will perform 4 sessions of 20 minutes treadmill walking. The first session serves as a control session in which patients will walk without VR. The order of the OF speed (i.e. matched, two times slower than and two times faster than their walking speed) in the following 3 VR sessions will be randomized.

PROCEDURE: Patients will be tested during 4 sessions of treadmill walking in the research lab of the research group R&MM at the Vrije Universiteit Brussel.

Prior to the start of each session, some preparations will have to be done with regard to the outcome measures:

  • Surface electrodes will be placed bilateral on the M. rectus femoris, M. vastus lateralis, M. semitendinosus (hamstrings medialis), M. tibialis anterior, M. gastrocnemius medialis and M. soleus. Electrode placement will follow the SENIAM guidelines. The skin underlying the electrode will be shaved and cleaned with alcohol to improve electrode-skin contact and reduce impedance.
  • Reflective markers will be placed on fixed points of the lower limbs of the patient. Marker placement will follow the Plug-in Gait lower body model (VICON).

Session 1: control session After these preparations, participants will be asked to fill in a questionnaire (the Simulator Sickness Questionnaire). Afterwards, participants will start to walk on the patient-controlled treadmill system. For safety only, participants will walk with an additional safety harness. Participants will first be habituated to walking on the treadmill. During this habituation, we will also check if all measurements (VICON and EMG) are correct and that no errors occur. If all measurements are good, participants will walk for 20 minutes on the treadmill. After these 20 minutes, the treadmill will be stopped and participants will be asked to fill in 2 questionnaires (the Simulator Sickness Questionnaire and the Physical Activity Enjoyment Scale).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • •diagnosed with stroke (as defined by the World Health Organization)
  • •stroke onset ≥ 6 months
  • •ambulatory with an impaired gait pattern (FAC-score 2 or 3 or 4)
  • •ability to walk on a treadmill for 20 minutes without bodyweight support
  • •adult (≥ 18 years)
  • •a body height between 155 cm and 200 cm
  • •ability to signal pain, fear and discomfort
  • •ability to give informed consent

排除标准

  • •other neurological deficits than stroke leading to impaired gait
  • •comorbidities (e.g. COPD, osteoporosis, cardiovascular instability)
  • •visual and/or vestibular disorders that can interfere with the VR
  • •uncontrolled spasticity significantly interfering with the movement of the lower extremities (Modified Ashworth Scale > 2)
  • •acute medical illness
  • •communicative/cognitive problems leading to the inability to understand and carry out instructions
  • •severe unilateral spatial neglect

研究组 & 干预措施

VR-enhanced treadmill walking

Experimental

Participants will be tested during 4 sessions of 20 minutes treadmill walking.

干预措施: Walking with different optic flow speeds (Other)

结局指标

主要结局

Muscle activity (EMG)

时间窗: Muscle activity will be measured continuously for 20 minutes and will be expressed per gait cycle

Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus medialis and lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis and lateralis) will be recorded continuously during treadmill walking with the use of surface electrodes.

Spatiotemporal gait parameters

时间窗: Spatiotemporal gait parameters will be measured continuously for 20 minutes and will be expressed per gait cycle

Spatiotemporal gait parameters of the lower limbs (i.e. walking speed, cadence, step length and - time, swing - and stance time, single - and double limb support period) during treadmill walking will be recorded continuously.

3D kinematic measurements

时间窗: Kinematic data will be measured continuously for 20 minutes and will be expressed per gait cycle

Kinematic data of the lower limbs (i.e. movement amplitudes of the bilateral hip, knee and ankle joint) during treadmill walking will be recorder continuously.

次要结局

  • Simulator Sickness Questionnaire (SSQ)(The SSQ will be assessed twice per session (session 1 - 2 - 3 - 4): immediately before and after the participants walked for 20 minutes.)
  • Number of falls or stumbles(The number of falls or stumbles will be assessed continuously for 20 minutes when patients are walking on the treadmill. The number of falls will be collected for each walking session (session 1 - 2 - 3 - 4).)
  • Physical Activity Enjoyment Scale (PACES)(The PACES will be assessed once per session (session 1 - 2 - 3 - 4): immediately after the participants walked for 20 minutes.)

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 (1)

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