NeuroRecoVR: Phase I Split-Belt Treadmill Dosing for Subacute Stroke
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dose Tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke survivors
- •First stroke
- •Over 18 years old
- •Between one week and three months post-stroke
- •can understand task instructions.
排除标准
- •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)
研究组 & 干预措施
Intervention - Dose Escalation
Participants enrolled into split-belt treadmill dose currently being tested
干预措施: Split-Belt Treadmill (Behavioral)
结局指标
主要结局
Dose Tolerability
时间窗: 5 days
Dose tolerability, defined as the presence, or lack thereof, any of the following dose-limiting criteria: * Participant requests to stop/declines to participate in any more sessions during the intervention period * Participant requests to stop before completing ≥80% of a session, 2+ times during the intervention period, for an intervention-related reason * Unfeasible to deliver ≥80% of a session, two or more times during the intervention period for organizational or environmental constraints * Unable to complete activities of their daily routine within 24 hours after their session * Therapist requests to stop before completing ≥80% of a single session 1+ times during the intervention period due to therapist fatigue * Participants cannot ramp up to the intended dose level within 3 days. * The therapist requests to stop before completing ≥80% of a single session 1+ times during the intervention period due to poor walking quality * Participant experiences attributable adverse event
次要结局
未报告次要终点
研究者
Dr. Sean Dukelow
Principal investigator
University of Calgary
