Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Dynamic Motor Control Index (DMCI)
研究概览
简要总结
Stroke survivors often experience impaired neuromechanical control that limits walking speed and quality, particularly due to deficits in paretic propulsion. This study aims to identify patient-specific neuromechanical locomotor control strategies, link them to biomechanical gait impairments, and investigate how these strategies influence responses to soft robotic exosuit assistance of paretic propulsion and ground clearance during walking. The study focuses on adults who are more than six months post-stroke and have observable gait deficits.
The main questions are:
- How do neuromechanical control patterns (i.e., electromyography-measured muscle coordination) affect walking speed, quality, and gait biomechanics after stroke?
- Do individuals with distinct neuromechanical patterns respond differently to robotic exosuit-assisted gait rehabilitation?
Researchers will compare walking performance without and with robotic exosuit assistance to determine whether tailoring exosuit-assisted gait intervention to patient-specific neuromechanical profiles can lead to greater improvements in walking function. Participants will complete treadmill and overground walking assessments instrumented with motion capture, EMG, and force plates, performing one trial without assistance and two trials with robotic exosuit assistance delivered at different assistance onset timings, from which a preferred assistance setting will be identified. The walking trial associated with the preferred assistance setting will be used for primary analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •At least 18 years old
- •>6 months post-stroke
- •Observable gait deficits
- •Able to walk overground and on a treadmill without body-weight support
- •Able to communicate clearly with investigators and follow instructions
- •Able to fit the exosuit components, including height between 4'8" and 6'7", weight < 264lbs, neutral ankle dorsiflexion during standing.
排除标准
- •Comorbidities besides stroke that impair walking (musculoskeletal, cardiovascular, pulmonary, or neurological)
- •Severe pain, neglect, hemianopia, or aphasia limiting comprehension
- •Unexplained dizziness or more than 2 falls in the previous month
- •Inability to communicate (as assessed by a licensed physical therapist)
- •Inability to wear the exosuit due to conditions that require medical management, such as open wounds or broken skin, or as assessed by a licensed physical therapist.
研究组 & 干预措施
Walking with and without robotic ankle assistance
Subjects will complete a 3-minute treadmill walking trial with and without robotic ankle assistance
干预措施: Walking with robotic ankle assistance (Device)
结局指标
主要结局
Dynamic Motor Control Index (DMCI)
时间窗: Baseline, Assisted (on average 1-2 hours)
Difference in neuromuscular control quality compared to normative data with and without exosuit
Correlation Between Propulsion and Weight-Acceptance Motor Modules (Temporal)
时间窗: Baseline, Assisted (on average 1-2 hours)
Difference in the merging of motor module structures quantified by correlation coefficient between the propulsion temporal module and weight-acceptance temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit
Correlation Between Weight-Acceptance and Swing-Limb Deceleration Motor Modules (Temporal)
时间窗: Baseline, Assisted (on average 1-2 hours)
Difference in the merging of motor module structures quantified by correlation coefficient between the weight-acceptance temporal module and swing-limb deceleration temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit
Variance Accounted For (VAF) by Four Muscle Synergies
时间窗: Baseline, Assisted (on average 1-2 hours)
Difference in the variance in muscle activation accounted for by the 4-synergy model, measuring the quantitative shift in muscle coordination complexity with and without exosuit (%)
Paretic Propulsion
时间窗: Baseline, Assisted (on average 1-2 hours)
Difference in anterior-posterior ground reaction force with and without exosuit (N)
Dynamic Motor Control Index (DMCI)
时间窗: Assisted - Baseline
Difference in neuromuscular control quality compared to normative data with and without exosuit
Correlation Between Propulsion and Weight-Acceptance Motor Modules (Temporal)
时间窗: Assisted - Baseline
Difference in the merging of motor module structures quantified by correlation coefficient between the propulsion temporal module and weight-acceptance temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit
Variance Accounted For (VAF) by Four Muscle Synergies
时间窗: Assisted - Baseline
Difference in the variance in muscle activation accounted for by the 4-synergy model, measuring the quantitative shift in muscle coordination complexity with and without exosuit (%)
Paretic Propulsion
时间窗: Assisted - Baseline
Difference in anterior-posterior ground reaction force with and without exosuit (N)
Correlation Between Weight-Acceptance and Swing-Limb Deceleration Motor Modules (Temporal)
时间窗: Assisted - Baseline
Difference in the merging of motor module structures quantified by correlation coefficient between the weight-acceptance temporal module and swing-limb deceleration temporal module, computed from EMG data by non-negative matrix factorization, with and without exosuit
次要结局
- Joint Angle(Baseline, Assisted (on average 1-2 hours))
- Joint Torque(Baseline, Assisted (on average 1-2 hours))
- Joint Power(Baseline, Assisted (on average 1-2 hours))
- Joint Angle(Assisted - Baseline)
- Joint Torque(Assisted - Baseline)
- Joint Power(Assisted - Baseline)
研究者
Lou Awad, PT, DPT, PhD
Associate Professor
Boston University Charles River Campus