NCT07469163 Phase I Split-Belt Treadmill Dosing for Subacute Stroke
| NCT ID | NCT07469163 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Calgary |
| Condition | Subacute Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2026-03-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After experiencing a stroke, many individuals encounter difficulties with walking and balance, which can significantly impact their independence. Recent studies have indicated that split-belt treadmill (SBT) training is effective for improving gait metrics, including walking speed and step length asymmetry. The SBT allows each leg to move at different speeds, which has been shown to help chronic stroke survivors learn to walk more symmetrically. However, there is limited knowledge about the dose participants should receive and the safety of SBT training in the early stages of recovery, which is a crucial period for rehabilitation. To address this gap, we are evaluating an innovative SBT with virtual reality (VR) features at the Foothills Medical Center. Our objective is to conduct a study to determine the amount of SBT training patients can tolerate in a day. In this study, stroke survivors will engage in a series of walking exercises on the SBT. We will escalate the duration of SBT walking until participants reach a point where they can no longer continue due to dose-limiting criteria such as fatigue or discomfort. The findings from this initial phase will guide future larger trials to explore the effectiveness of this training method. Ultimately, we aspire to improve rehabilitation strategies for stroke survivors, assisting them in regaining mobility and enhancing their quality of life more effectively.
Eligibility Criteria
Inclusion Criteria: * Ischemic or hemorrhagic stroke survivors * First stroke * Over 18 years old * Between one week and three months post-stroke * can understand task instructions. Exclusion Criteria: * History of significant neurological diseases (e.g. Multiple Sclerosis, Parkinson's disease) * Orthopedic issues in lower extremities (e.g. severe knee Osteoarthritis) * Excessive pain preventing participants from participating in treadmill-based activities * Cerebellar stroke * Body weight more than 560 lbs (this exceeds the weight limit of the support harness)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07469163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subacute Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07469163 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07469163 currently recruiting?
Yes, NCT07469163 is actively recruiting participants. Contact the research team at alexa.boyer1@ucalgary.ca for enrollment information.
Where is the NCT07469163 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT07469163 clinical trial?
NCT07469163 is sponsored by University of Calgary. The trial plans to enroll 72 participants.
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