Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- strength
研究概览
简要总结
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke survivors < 4 weeks from most recent stroke.
- •Age: 21- 80 years
- •Unilateral hemiparesis
- •Medical clearance by a Kessler Institute for Rehabilitation physician.
- •Be able to physically fit into the exoskeleton device.
- •Be able to tolerate upright standing for 30 minutes.
- •Have joint range of motion within normal functional limits for ambulation.
- •Have sufficient strength to use the hemiwalker, bilateral canes or walker while wearing the RE.
- •Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
- •Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions as determined by a Kessler Institute for Rehabilitation physician or physical therapist.
- •No history of injury or pathology to the unaffected limb.
排除标准
- •Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
- •Joint contracture or spasticity of any limb that limits normal ROM during ambulation with assistive devices.
- •Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
- •Skin issues that would prevent wearing the device.
- •Pressure sore stage 2 or higher located in an area that would negatively affect weight bearing, harness fit, or therapist assistance.
- •Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
- •Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- •Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
- •History of severe cardiac disease such as myocardial infarction, congestive heart failure.
- •Uncontrolled seizure disorder.
- •Uncontrolled spasticity that would interfere with walking in the RENeuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
- •Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
- •Pregnant as confirmed by pregnancy test.
结局指标
主要结局
strength
时间窗: 6 months
conventional assessment performed by a physical therapist
TUG
时间窗: 6 months
time up and go (TUG) test
BBA
时间窗: 6 months
Berg Balance Assessment (BBA)
ROM
时间窗: 6 months
range of motion (ROM)- conventional assessment performed by a physical therapist
SIS
时间窗: 6 months
stroke impact scale (SIS). questionnaire about quality of life post-stroke
LIFE-H
时间窗: 6 months
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
SSQoL
时间窗: 6 months
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
electromyography (EMG)
时间窗: 6 months
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
temporal spatial parameters
时间窗: 6 months
collected though motion capture camera system
Functional Independence Measure (FIM)
时间窗: 6 months
a conventional assessment measure of motor function
plantar loading
时间窗: 6 months
use of shoe insoles to gather information about foot pressure
次要结局
未报告次要终点