VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
研究概览
简要总结
VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical [PV] and visual vertical [VV]), which in turn might affect body orientation (head and trunk). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.
详细描述
This project proposes to test the effect of immersion in a tilted virtual reality on verticality representation in hemisphere stroke patients showing lateropulsion and in healthy participants. The idea is to use the virtual reality as a tool to recalibrate the internal reference of verticality (contralesionally biased) in stroke patients and to experimentally create a bias in verticality perception of healthy participants, then to investigate how this modulation of the internal model of verticality might affect the erect posture. The investigators hypothesize that, in stroke patients, the recalibration of the verticality perception might ameliorate their lateropulsion, whereas in healthy participants, the experimental verticality bias introduced might induce a transient experimental lateropulsion. A transmodal modulation of the verticality perception, both on PV and VV, would imply a modulation by the virtual reality not only at the level of perception but also at the internal model of verticality, advocating for a powerful effect of this technology. The analysis of a post-effect (on verticality perception) that would continue after the intervention (immersion in the virtual titled room) would be a supplementary argument advocating for its clinical use in rehabilitation of post-stroke lateropulsion. To judge the effect of the immersion in tilted virtual reality, the following measures will be considered: (a) PV perception, (b) VV perception, (c) body orientation measured by inertial captors, and (d) weight-bearing asymmetry in erect posture assessed by posturography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants know the intervention condition but not the effect expected. Assessor knows the intervention condition for the primary outcome change in PV, and the secondary outcomes, changes in VV, body orientation, and weight bearing asymmetry.
Assessor blind of the intervention condition for the assessment of the secondary criteria lateropulsion (SCALA) and balance in daily life (PASS)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 stroke participants
- •Hospitalized in neurorehabilitation
- •Hemisphere stroke (Right or left)
- •Stroke delay < 6 months
- •Presence of lateropulsion assessed by the Scale for Contraversive Pushing (SCP) > 0.5
- •20 healthy participants
- •No history of stroke or others neurological pathologies
- •No balance disorders
- •No history of vestibular or dizzissness disorders
排除标准
- •History of psychiatric disorders
- •Nyctophobia
- •Advanced heart failure
- •Severe trunk deformation with C7 lateral > 30 mm due to a independant cause beyond the stroke (i.e., scoliosis) or history of postural disorder
- •20 Stroke participants
- •Medical instability making the assessment impossible
- •Comprehension deficits with Boston Diagnostic Aphasia Examination gravity score ≥3
- •History of vestibular or dizzissness disorders
- •No previous neurological history interfering with balance
- •Inability to understand and execute simple orders
- •Severe untreated depression (Aphasic Depression Rating Scale (ADRS) score >15)
研究组 & 干预措施
Plane A for the cross-over (Immersion in a virtual tilted room)
Half of participants will perform the experiment according the plane A, which corresponds to the following order: verticality perception (Baseline, effect during the intervention, post-effect), then active vertical body orientation (Baseline, effect during the intervention). The intervention is an immersion in a virtual static and tilted environnement (18°).
During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day.
干预措施: Virtual Reality , immersion in a virtual titlted room (Other)
Plane B for the cross-over (Immersion in a virtual tilted room)
Half of participants will perform the experiment according the plane B, which corresponds to the following order: active vertical body orientation (Baseline, effect during the intervention), then verticality perception (Baseline, effect during the intervention, post-effect). The intervention is an immersion in a virtual static and tilted environnement (18°).
During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day.
干预措施: Virtual Reality , immersion in a virtual titlted room (Other)
结局指标
主要结局
Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
时间窗: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
PV consists of testing the whole body orientation in sitting, perceived as vertical by participants, in complete darkness. PV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008). PV orientation will be the average orientation (in degree) of the 10 trials performed for each condition.
次要结局
- Awareness of the changes in active vertical body orientation. Evaluation of participants' awareness of the changes in body orientation and balance in standing posture induced by virtual reality.(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), at baseline, with average values (2 sessions)(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Effect on lateropulsion. Change from baseline in lateropulsion scores assessed by the SCAle for LAteropulsion after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants.(45 minutes every Friday during the protocol (W0, W1, W2, W3).)
- Effect on postural capacities. Change from baseline in balance scores assessed by the modified Postural Assessment Scale for Stroke patient after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants(45 minutes every Friday during the protocol (W0, W1, W2, W3).)
- Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), during the virtual reality, with average values (2 sessions).(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Description of symptoms in case of Virtual reality sickness.(Days 1, 2, 3 and 4 of the W2)
- Post-effect on PV. Change from baseline in PV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.(Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2)
- Responders to virtual reality. Proportion of participants in whom the immersion in a virtual tilted room modulates PV (at least 2 degrees).(Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2)
- Quantification of a possible Virtual reality sickness.(Days 1, 2, 3 and 4 of the W2)
- Changes in the visual perception of the vertical (VV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.(Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2)
- Modulation of active vertical pelvis orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Post-effect on VV. Change from baseline in VV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.(Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2)
- Modulation of active vertical trunk orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Modulation of active vertical head orientation. Change from baseline in active vertical head orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Changes in weight-bearing asymmetry. Evaluation of changes in weight-bearing asymmetry in standing posture before and during the immersion in a virtual tilted room, in stroke and healthy participants.(Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2)
- Influence of verbal instruction on standing posture(Days 1, 2, 3 and 4 of the W2)