Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Paretic Leg Propulsive Force
研究概览
简要总结
This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.
详细描述
The purpose of this study is to assess the effectiveness of an integrated gait training paradigm that combines mechanical task constraints and sensory feedback during split-belt treadmill walking to enhance paretic leg propulsion and improve propulsion symmetry in individuals post-stroke. The risks associated with this study are lower than those encountered during daily walking in the community and in typical physical therapy clinics, where patients with physical impairments routinely engage in challenging exercises to improve their abilities. There is a slight possibility of local skin irritation or rash resulting from the non-allergenic adhesive tape or sensor gel used to attach the EMG sensors. This is a rare occurrence and typically resolves within one to two days without medical intervention.
This study will last approximately one to two hours, depending on your condition, and involves a one-time visit.
If you choose to participate in this study, the participant will be asked to:
- Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies.
- Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored.
- Assess your walking capacity.
- Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20 years or older
- •For stroke group: clinical diagnosis of stroke at least 1 month prior to participation
- •Ability to walk at least 10 meters with or without assistive devices
- •For healthy group: able to walk independently without assistive devices
排除标准
- •Life expectancy less than one year
- •Comatose or unable to follow three-step commands
- •Amputation of any lower limb
- •Poorly controlled diabetes (e.g., foot ulceration)
- •Progressive neurological disease
- •Medically unstable condition
- •Significant musculoskeletal impairments affecting gait
- •Congestive heart failure or unstable angina
- •Peripheral vascular disease
- •Severe neuropsychiatric conditions (e.g., dementia, cognitive deficits, severe depression)
研究组 & 干预措施
Gait Training with Combined Sensory Feedback and Mechanical Constraints
All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.
干预措施: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions (Behavioral)
Gait Training with Combined Sensory Feedback and Mechanical Constraints
All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.
干预措施: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity (Behavioral)
Gait Training with Combined Sensory Feedback and Mechanical Constraints
All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.
干预措施: Sensory Feedback Training (Behavioral)
结局指标
主要结局
Change in Paretic Leg Propulsive Force
时间窗: Within a single session (approximately 2 hours)
Peak anterior ground reaction force of the paretic leg will be measured using an instrumented split-belt treadmill . Changes in propulsive force under different treadmill and resistance/feedback conditions will be analyzed to evaluate improvements in gait symmetry.
次要结局
- Stride Length (m) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking(Day 1 (during treadmill and overground walking trials))
- Step Length (m) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System(Day 1 (during treadmill walking trials))
- Walking Speed (m/s) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Cadence (steps/min) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Swing Time (s) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Stance Time (s) During Overground Walking Using Zeno Walkway(Day 1 (during overground walking trials))
- Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System(Day 1 (during treadmill walking trials))
- Ankle Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System(Day 1 (during treadmill walking trials))