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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Dose Escalation | Experimental | Participants enrolled into split-belt treadmill dose currently being tested |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split-Belt Treadmill | Behavioral | Participants undertake 5 days of treadmill walking. Each day is broken into 3 episodes: A) two-minutes tied-belt walking, B) n minutes split-belt walking (dose escalating component), C) 10-minutes tied-belt walking. Split-belt walking will start at a dose of 8-minutes and escalate by 3 minute increments, up to a maximum dose of 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Tolerability | Dose tolerability, defined as the presence, or lack thereof, any of the following dose-limiting criteria:
| 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexa Boyer | Contact | 5193594643 | alexa.boyer1@ucalgary.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital | Recruiting | Calgary | Alberta | T2N2T9 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a Phase I dose-ranging trial utilizing a rule-based A+B design. The primary goal of this investigation is to employ a dose escalation paradigm to ascertain the maximum tolerated dose of split-belt walking in a day. For each investigated dose, three participants (A) are recruited. If all participants tolerate the dose, three more participants (A) are recruited and enrolled at the next available dose. If dose limiting criteria is met for one of the three participants (A), three more participants (B) are recruited and enrolled at the current dose.
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|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |