Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT06495450
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06495450
Study Brief:
Protocol Section:
NCT06495450