Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

Официальное название

PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors

Обзор

The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes. Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors. Participants will: * undergo a 45-minute training session 3 times per week for 12 weeks * intervention group: omni-VR * control group: traditional exercise program (strengthening and walking activities)

Подробное описание

Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.

Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.

Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.

Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors

Вмешательства

• Устройство Omnidirectional Virtual Reality and Treadmill Training
  Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.
• Поведенческое Traditional Exercise
  A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

Первичные конечные точки

• Consent rate [Срок оценки: Baseline]
• Retention rate [Срок оценки: 12 weeks (study completion)]
• Usability of the Omnidirectional Treadmill and Virtual Reality Game [Срок оценки: 12 weeks (study completion)]
• Participant burden [Срок оценки: Baseline and 12 weeks (study completion)]
• Adherence [Срок оценки: 12 weeks (study completion)]
• Equipment downtime [Срок оценки: 12 weeks (study completion)]
• Equipment safety [Срок оценки: 12 weeks (study completion)]

Вторичные конечные точки (9)

• Cognitive function [Срок оценки: Baseline and 12 weeks (study completion)]
• Executive Function [Срок оценки: Baseline and 12 weeks (study completion)]
• Working memory [Срок оценки: Baseline and 12 weeks (study completion)]
• Brain activation in prefrontal and premotor cortices [Срок оценки: Baseline and 12 weeks (study completion)]
• Walking Speed [Срок оценки: Baseline and 12 weeks (study completion)]
• Step cadence [Срок оценки: Baseline and 12 weeks (study completion)]
• Step width [Срок оценки: Baseline and 12 weeks (study completion)]
• Step length [Срок оценки: Baseline and 12 weeks (study completion)]
• Dynamic balance [Срок оценки: Baseline and 12 weeks (study completion)]

Критерии участия

Критерии включения

• Age ≥ 18
• Stroke ≥ 6 months ago (confirmed with chart review)
• Living within 50 km of Halifax, Nova Scotia
• Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.
• Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.
• No uncorrected visual deficits or spatial neglect
• No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance
• Can follow simple instructions
• Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.

Критерии исключения

• Unstable serious medical condition
• Resting blood pressure >180/100mmHg
• History of abnormal untreated heart rhythm
• Pregnancy
• Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain)
• Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)
• Severe loss of hearing or speech that would preclude VR use
• Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill)
• Participating in another formal lower limb exercise program > 1 day per week
• History of QT prolongation or using potential QT prolonging drugs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Nova Scotia Rehabilitation & Arthritis Centre — Halifax

Идентификаторы

NCT: NCT06495450 · PROVE_stroke

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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