Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-20
Brief Title:
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
PROVE-VR A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE
Brief Summary:
The primary objective of this pilot randomized controlled trial RCT is to test the feasibility recruitment 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
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
Detailed Description:
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 users 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
Virtual reality or VR a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the users 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None