WALKING WITH VIRTUAL REALITY: How Does Optic Flow Speed and Level of Immersion Influence the Gait Pattern in People Post-stroke?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Walking speed
研究概览
简要总结
The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Furthermore, the study will also investigate if the level of immersion has an effect on the rehabilitation outcomes by manipulating the optic flow speed in two different VR devices: the semi-immersive GRAIL system and the fully-immersive 'Oculus Rift S' HMD.
To properly understand the results of the people with a stroke, we will also investigate the effect of manipulating the optic flow speed and the level of immersion on the gait pattern in healthy people. That way, we can investigate whether virtual reality has a different influence on the gait pattern of people with a stroke than in healthy people.
详细描述
STUDY DESIGN
This study is an experimental, 2-group, multicenter trial in which people post-stroke and healthy people will perform 2 different sessions of treadmill walking. The 2 sessions will be carried out on 2 separate days within 10 days. Both sessions will be identical, only the VR system used to manipulate the optic flow speed will differ. The order of the 2 sessions and the optic flow speed manipulation will be randomized.
MATERIALS
GRAIL system: The Gait Real-time Interactive Lab (GRAIL) is an integrative motion capture system consisting of 10 optical motion cameras (Vicon Inc., Oxford, UK), a dual belt treadmill with integrated force plates, a 180-degree cylindrical projection screen system, and D-Flow software (Motekforce Link, Amsterdam, Netherlands). The treadmill of the GRAIL system has two modes: fixed walking speed or self-paced. For this study, the treadmill will be self-paced, meaning that the patient is in control and can choose the walking speed. The treadmill will follow the walking speed of the patient, which allow the patient to start, stop and change speed at will. The projection screen of the GRAIL system will assure a semi-immersive virtual environment. The GRAIL system is located in the Smart Space lab (UZ Gent) and will be made available at the researchers of the VUB/UZ Brussel.
Head-mounted display (HMD): The HMD VR system 'Oculus Rift S' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. The "Oculus Rift S" will assure a fully immersive virtual environment. The researchers of the VUB/UZ Brussel have the HMD 'Oculus Rift S' in their possession and will make it available for the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •stroke patients:
- •diagnosed with stroke (as defined by the World Health Organization)
- •stroke onset ≥ 3 months
- •ambulatory with an impaired gait pattern (FAC-score 2, 3 or 4)
- •ability to walk on a treadmill for 4x8 minutes without bodyweight support
- •adult (≥ 18 years)
- •ability to signal pain, fear and discomfort
- •ability to give informed consent
排除标准
- •stroke patients:
- •other neurological deficits than stroke leading to impaired gait (e.g. Parkinson's disease, multiple sclerosis)
- •comorbidities (e.g. COPD, severe 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
- •Inclusion Criteria healthy people:
- •≥ 18 years of age
- •normal or corrected-to-normal vision with glasses or contact lenses,
- •no locomotion impairments
- •Exclusion Criteria healthy people:
- •having a significant lower extremity injury during the last two years that might affect their gait
- •having any type of vestibular/visual deficiency
研究组 & 干预措施
VR-enhanced treadmill walking
Participants will be tested during 2 sessions of VR-enhanced treadmill walking.
干预措施: Walking with different optic flow speeds with 2 different VR devices (Other)
结局指标
主要结局
Walking speed
时间窗: through study completion, an average of 1 year
Walking speed (m/s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
3D kinematic measurements lower limb
时间窗: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
3D kinematic measurements upper limb (arm swing)
时间窗: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the bilateral shoulder, elbow and wrist joint in degrees) of the upper limb during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz. With these data, information about the arm swing during walking will be obtained.
3D kinetic measurements lower limb
时间窗: through study completion, an average of 1 year
Kinetic data (i.e. forces, moments and powers of the bilateral hip, knee and ankle joint in respectively Newton, Newton-meters and Watt) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Cadence
时间窗: through study completion, an average of 1 year
Cadence (steps/min) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Step length
时间窗: through study completion, an average of 1 year
Step length (cm) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Swing - and stance time
时间窗: through study completion, an average of 1 year
Swing and stance time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Single - and double limb support period
时间窗: through study completion, an average of 1 year
Single and double limb support period (% gait cycle) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Step time
时间窗: through study completion, an average of 1 year
Step time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Lower limb muscles activity
时间窗: through study completion, an average of 1 year
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
Upper limb muscles activity
时间窗: through study completion, an average of 1 year
Muscle activity of the upper limb muscles (bilateral: M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
次要结局
- Simulator Sickness Questionnaire(through study completion, an average of 1 year)
- Igroup Presence Questionnaire(through study completion, an average of 1 year)
- Visual Analogue Scale(through study completion, an average of 1 year)
- Number of falls or stumbles(through study completion, an average of 1 year)
研究者
Emma De Keersmaecker
Principal Investigator
Vrije Universiteit Brussel