Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic Using a Wearable Propulsion Neuroprosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Six Minute Walk Test (6MWT) Speed
研究概览
简要总结
The primary goal of this study is to understand the feasibility and rehabilitative effects of a Neurostimulation Exosuit Augmented Training (NEAT) program designed to provide high-intensity gait training in progressively challenging environments for individuals in the chronic phase of stroke recovery. The investigators will monitor feasibility of the training program and assess walking endurance and energy efficiency before and after the training to quantify effects of the training program on the recovery of walking function driven by improvements in forward propulsion and symmetry between limbs. Participants will complete pre-training and post-training evaluations alongside 12 gait training sessions across 4-5 weeks.
详细描述
Functional electrical stimulation (FES) is commonly used to manage foot drop in people with post-stroke hemiparesis. Emerging use of FES applied to the paretic plantarflexors to facilitate push-off ability during walking has been limited to the treadmill and highly supervised laboratory-based settings. This novel neurostimulation exosuit (i.e., neuroprosthesis) enables overground gait training in environments of varying complexity by giving clinicians the ability to modulate neurostimulation timing and intensity delivered to the dorsiflexors for swing-phase foot clearance and to the plantarflexors for stance-phase plantarflexor forward propulsion. Combined with progressive, high-intensity, task-specific gait training, as has been performed previously with soft robotic exosuits developed by the same research group, this propulsion neuroprosthesis will leverage i) immediate gait assistance from the neurostimulation to facilitate high intensity training without sacrificing gait quality and ii) neurorestorative properties of FES to encourage the recovery motor function to affected muscles.
The primary objective of this study seeks to understand the feasibility and rehabilitative effects of a Neurostimulation Exosuit Augmented Training (NEAT) program designed to provide high-intensity speed-driven gait training in progressively challenging environments. The investigators hypothesize that the NEAT program will safely provide a standard dose of gait rehabilitation training within a clinic setting and that the training will result in clinically meaningful gains in walking endurance and energy efficiency driven by improvements in forward propulsion and symmetry between limbs.
Secondary objectives of this study seek to assess the effects of the NEAT program on neuromuscular control to the paretic plantarflexors (i.e., central drive). The investigators hypothesize that repeated training with neurostimulation to the dorsiflexors and plantarflexors will result in increased neuromuscular control to the paretic plantarflexors.
The NEAT program will consist of 14 total study visits: i) Pre-training Evaluation, ii) NEAT Training (12 sessions, 2-3 times per week), iii) Post-training Evaluation. The neurostimulation exosuit used in this study was developed for investigational use only by investigators at the Boston University Neuromotor Recovery Laboratory, the Harvard University BioDesign Lab, and the Harvard University Move Lab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years old
- •History of stroke event occurring at least 6 months ago
- •Observable gait deficits characteristic of post-stroke hemiparesis
- •Independent ambulation for at least 30 meters (with an assistive device if needed but without a rigid brace for the ankle)
- •Ankle dorsiflexion range of motion at least to neutral (i.e., 90 degrees between the shank and the foot)
- •Resting heart rate between 40 - 100 bpm (inclusive)
- •Resting blood pressure between 90/60 and 170/90 mmHg (inclusive)
- •HIPAA authorization to allow communication with healthcare provider as needed during the study period
- •Medical clearance by a physician
排除标准
- •NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- •Inability to communicate with investigators
- •Visual neglect or hemianopia
- •History of cerebellar stroke
- •Actively receiving physical therapy for walking
- •More than 2 unexplained falls in the previous month
- •Pressure ulcers or skin wounds located near human-device interface sites
- •Pacemakers or similar electrical implants that could be affected by electrical stimulation
- •Metal implants directly under the stimulation sites
- •Skin allergy or other condition sensitive to the adhesive from transcutaneous neurostimulation electrode pads
- •Other medical, orthopedic, and neurological conditions that prevent full participation in the research
结局指标
主要结局
Six Minute Walk Test (6MWT) Speed
时间窗: Post-training Evaluation (average of 5 weeks)
Walking speed is assessed during the 6MWT at each reference length completed (e.g., 30-meter stretch before turning around). Speed is calculated as the reference length divided by the time it took to walk that distance in meters per second (m/s). This metric is assessed during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).
Energy Expenditure
时间窗: Post-training Evaluation (average of 5 weeks)
Energy expenditure assessed using indirect calorimetry (COSMED K5) and is calculated as the volume of oxygen inhaled normalized by bodyweight and distance (mL O2/kg/m). This metric will be measured during the 6MWT performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).
Ten Meter Walk Test (10mWT) Speed
时间窗: Post-training Evaluation (average of 5 weeks)
This is a clinical test of short-distance walking function. The participant walks at a comfortable walking speed (CWS) and fast walking speed (FWS) on a 10-meter straight walkway. The middle six meters are used to assess speed across 3 trials for CWS and 3 trials for FWS.
Plantarflexor Central Drive
时间窗: Post-training Evaluation (average of 5 weeks)
Central drive is a measure of voluntary control of a muscle. The participant uses their plantarflexors to push into a torque-sensing plate. Upon reaching the plateau of a maximum voluntary contraction (MVC), a burst of electrical stimulation is delivered using the burst superimposition technique to activate any remaining muscle fibers that are not activated volitionally, obtaining the maximum force-generating ability (MFGA). Central drive is calculated as the ratio of MVC to MFGA as a percentage (i.e., 100% central drive indicates full voluntary control of the muscle). Paretic plantarflexor central drive is assessed every 3-4 training days.
Gait Propulsion
时间窗: Post-training Evaluation (average of 5 weeks)
Propulsion is the anterior component of the ground reaction force corresponding to the push-off subtask of walking that propels a forward into the next step. Gait propulsion is assessed during the 6MWT using floor-embedded forceplates.
Six Minute Walk Test (6MWT) Distance
时间窗: Post-training Evaluation (average of 5 weeks)
This is a clinical test of long-distance walking function. The participant walks as far as they can safely in 6 minutes. Total distance covered in 6 minutes is the primary outcome from this test. This test will be performed without a neuroprosthesis (unassisted) and with electrical stimulation assistance from a neuroprosthesis (assisted).
次要结局
- System Usability Scale (SUS)(Last Training Day (Day 12))
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) - Modified(Last Training Day (Day 12))
研究者
Lou Awad, PT, DPT, PhD
Associate Professor, Physical Therapy
Boston University Charles River Campus