Uso de realidad virtual omnidireccional y entrenamiento en cinta rodante para accidentes cerebrovasculares crónicos (PROVE)
PROVE-VR: ensayo piloto aleatorizado que utiliza realidad virtual omnidireccional y entrenamiento en cinta rodante para supervivientes de accidentes cerebrovasculares crónicos
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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Adria Quigley, PhD
- Número de teléfono: 902-494-2734
- Correo electrónico: adriaquigley@dal.ca
Ubicaciones de estudio
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 4K4
- Reclutamiento
- Nova Scotia Rehabilitation & Arthritis Centre
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Contacto:
- Adria Quigley, PhD
- Número de teléfono: 902-494-2734
- Correo electrónico: adriaquigley@dal.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- 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.
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Omni-VR group
20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using 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. |
|
Comparador activo: Control group
10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks. |
A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Consent rate
Periodo de tiempo: Baseline
|
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%. |
Baseline
|
|
Retention rate
Periodo de tiempo: 12 weeks (study completion)
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Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group. |
12 weeks (study completion)
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Usability of the Omnidirectional Treadmill and Virtual Reality Game
Periodo de tiempo: 12 weeks (study completion)
|
Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants. |
12 weeks (study completion)
|
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Participant burden
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit. |
Baseline and 12 weeks (study completion)
|
|
Adherence
Periodo de tiempo: 12 weeks (study completion)
|
Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions. |
12 weeks (study completion)
|
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Equipment downtime
Periodo de tiempo: 12 weeks (study completion)
|
The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions. |
12 weeks (study completion)
|
|
Equipment safety
Periodo de tiempo: 12 weeks (study completion)
|
The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study |
12 weeks (study completion)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cognitive function
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will use the Computerized MoCA [Montreal Cognitive Assessment] Duo to evaluate participants' cognitive function. |
Baseline and 12 weeks (study completion)
|
|
Executive Function
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function. |
Baseline and 12 weeks (study completion)
|
|
Working memory
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory. |
Baseline and 12 weeks (study completion)
|
|
Brain activation in prefrontal and premotor cortices
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
Brain activation using fNIRS [Functional near-infrared spectroscopy] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test) |
Baseline and 12 weeks (study completion)
|
|
Walking Speed
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
Walking speed using VIVE trackers on omnidirectional treadmill and overground |
Baseline and 12 weeks (study completion)
|
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Step cadence
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will evaluate step cadence using the VIVE trackers. |
Baseline and 12 weeks (study completion)
|
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Step width
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will evaluate step width using the VIVE trackers. |
Baseline and 12 weeks (study completion)
|
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Step length
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will evaluate step length using the VIVE trackers. |
Baseline and 12 weeks (study completion)
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Dynamic balance
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance. |
Baseline and 12 weeks (study completion)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Motivation of participant
Periodo de tiempo: 12 weeks (study completion)
|
The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results. |
12 weeks (study completion)
|
|
Health-related quality of life of participant
Periodo de tiempo: Baseline and 12 weeks (study completion)
|
The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results. |
Baseline and 12 weeks (study completion)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROVE_stroke
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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