Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke (PROVE)

Nova Scotia Health Authority (NSHA)

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Traditional Exercise; Device: Omnidirectional Virtual Reality and Treadmill Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06495450

PROVE_stroke

Details and patient eligibility

About

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)

Full 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 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Omni-VR group

Experimental group

Description:

20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.

Treatment:

Device: Omnidirectional Virtual Reality and Treadmill Training

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Traditional Exercise