Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNova Scotia Health Authority

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unstable serious medical condition

Resting blood pressure >180/100mmHg

History of abnormal untreated heart rhythm

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Omni-VR groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Consent rate

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

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Baseline and 12 weeks (study completion)

Secondary outcomes

Cognitive function

The investigators will use the Computerized MoCA \[Montreal Cognitive Assessment\] Duo to evaluate participants' cognitive function.

Time frame

Baseline and 12 weeks (study completion)

Executive Function

The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function.

Time frame

Baseline and 12 weeks (study completion)

Working memory

The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory.

Time frame

Baseline and 12 weeks (study completion)

Brain activation in prefrontal and premotor cortices

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)

Time frame

Baseline and 12 weeks (study completion)

Other outcomes

Motivation of participant

The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results.

Time frame

12 weeks (study completion)

Health-related quality of life of participant

The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results.

Time frame

Baseline and 12 weeks (study completion)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Dalhousie University

Sponsor institution

Brain Canada

Collaborator

Source ClinicalTrials.gov

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