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Идёт набор NCT04911738

VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical

Без фазы С лечением Stroke Brain Diseases Cerebrovascular Disorders Postural; Defect

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Reality , immersion in a virtual titlted room.
Кому может быть актуально
Состояния в реестре: Stroke, Brain Diseases, Cerebrovascular Disorders, Postural; Defect. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Virtual Reality , immersion in a virtual titlted room
    The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.

Первичные конечные точки

  • Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants. [Срок оценки: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2]
Вторичные конечные точки (12)
  • Changes in the visual perception of the vertical (VV) before and during the immersion in a virtual tilted room, in stroke and healthy participants. [Срок оценки: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B 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. [Срок оценки: Days 1 and 3 if assignment to plane A or days 2 and 4 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. [Срок оценки: 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. [Срок оценки: 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 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 45 minutes every Friday during the protocol (W0, W1, W2, W3).]
  • Responders to virtual reality. Proportion of participants in whom the immersion in a virtual tilted room modulates PV (at least 2 degrees). [Срок оценки: Days 1 and 3 if assignment to plane A or days 2 and 4 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. [Срок оценки: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2]
  • 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. [Срок оценки: 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) [Срок оценки: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • All
  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • University Hospital Grenoble — Grenoble

Публикации

  • Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4. PMID 18678565
  • Piscicelli C, Perennou D. Visual verticality perception after stroke: A systematic review of methodological approaches and suggestions for standardization. Ann Phys Rehabil Med. 2017 Jun;60(3):208-216. doi: 10.1016/j.rehab.2016.02.004. Epub 2016 Apr 11. PMID 27079584
  • Odin A, Faletto-Passy D, Assaban F, Perennou D. Modulating the internal model of verticality by virtual reality and body-weight support walking: A pilot study. Ann Phys Rehabil Med. 2018 Sep;61(5):292-299. doi: 10.1016/j.rehab.2018.07.003. Epub 2018 Jul 19. PMID 30031891
  • Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11. PMID 33177223
  • Dehem S, Piscicelli C, Lhommee E, Gimat R, Dai S, Marquer A, Hugues A, Perennou D. Modulating verticality representation and uprightness by virtual reality: rationale and protocol for a within-person randomised intervention associating a basic study in healthy individuals and a pilot clinical trial in individuals exhibiting post-stroke lateropulsion (VIRGIL). BMJ Open. 2025 Jun 18;15(6):e092406. d PMID 40533218

Идентификаторы

NCT: NCT04911738 · 2020-A02941-38

Первоисточники (государственные реестры)

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