Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

NCT06495450 | Recruiting

• 1 other identifier: PROVE_stroke
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Stroke

Keywords

Virtual Reality; Stroke rehabilitation; Omnidirectional treadmill

Outcome Measures

Primary Outcomes (7)

• Consent rate

  Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.

  Baseline

• Retention rate

  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)

• Usability of the Omnidirectional Treadmill and Virtual Reality Game

  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)

• Participant burden

  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

  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)

• Equipment downtime

  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

  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)

Secondary Outcomes (9)

• Cognitive function

  Baseline and 12 weeks (study completion)

• Executive Function

  Baseline and 12 weeks (study completion)

• Working memory

  Baseline and 12 weeks (study completion)

• Brain activation in prefrontal and premotor cortices

  Baseline and 12 weeks (study completion)

• Walking Speed

  Baseline and 12 weeks (study completion)

Other Outcomes (2)

• Motivation of participant

  12 weeks (study completion)

• Health-related quality of life of participant

  Baseline and 12 weeks (study completion)

Study Arms (2)

Omni-VR group

EXPERIMENTAL

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

Device: Omnidirectional Virtual Reality and Treadmill Training

Control group

ACTIVE COMPARATOR

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.

Behavioral: Traditional Exercise

Interventions

Omnidirectional Virtual Reality and Treadmill Training DEVICE

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.

Omni-VR group

Traditional Exercise BEHAVIORAL

A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Brain Canada: collaborator

Study Sites (1)

Nova Scotia Rehabilitation & Arthritis Centre

Halifax, Nova Scotia, B3H 4K4, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Adria Quigley, PhD

CONTACT

902-494-2734; adriaquigley@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 10, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): September 6, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CA (1)