Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Net heart rate (HR, beats/min) at minute 20 of walking
研究概览
简要总结
To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke
详细描述
STUDY DESIGN: An experimental, 1-group trial
PATIENT RECRUITMENT: A minimum of 10 subjects will be included in the study. Patients will be recruited at the Revarte Rehabilitation Hospital (Edegem, Belgium).
ELIGIBILITY CRITERIA: see section "Eligibility"
PROCEDURES: The trial will be conducted at the Revarte Rehabilitation Hospital (Edegem, Belgium).
Before the start of the study, informed consent and baseline patient characteristics will be collected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included will be persons who
- •Had a stroke (1 week to 6 months since injury)
- •Are 18 years or older
- •Cannot walk independently or can walk independently on level ground, but require help on stairs, slopes or uneven surfaces (FAC 0 - 4)
- •Have prior experience with the Ekso GT (i.e. 4 training sessions)
- •Excluded will be persons who
- •Can walk independently on level ground, stairs, slopes and uneven surfaces (FAC = 5)
- •Have musculoskeletal problems (other than stroke) affecting the ability to walk
- •Have concurrent pulmonary diseases (e.g. asthma)
- •Have unstable cardiovascular conditions
- •Have concurrent neurological diseases (e.g. Parkinson's Disease)
- •Have communicative and/or cognitive problems affecting the ability to understand or follow instructions
- •Present contra-indications for using the Ekso GT (according to manufacturer's instructions)
- •Severe concurrent medical diseases (infections, circulatory, heart or lung, pressure sores)
- •Severe spasticity (Ashworth 4)
- •Range of motion restrictions that would prevent a patient from achieving normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions
- •Bilateral hip flexion < 110°
- •Knee flexion contracture > 12°
- •Inability to achieve 0° neutral angle dorsiflexion with knee flexion ≤ 12°
- •Weight ≥ 100 kg
- •Hip width < 35.8 cm or > 45.6 cm
- •Upper leg length < 51 cm or > 61.4 cm
- •Lower leg length < 48 cm or > 63.4 cm
- •Upper leg length discrepancy > 0.5 inch (1.3 cm)
- •Lower leg length discrepancy > 0.75 inch (1.9 cm)
- •Unstable spine, unhealed limbs or pelvic fractures
- •Unhealthy bone density
- •Heterotopic ossification
- •Significant contractures
- •Elbows and shoulders cannot support crutches, walker or cane
- •Psychiatric or cognitive situations that may interfere with proper operation of the device
排除标准
- 未提供
研究组 & 干预措施
Ekso GT gait training
20-minute Ekso GT gait training
干预措施: Ekso GT (Device)
结局指标
主要结局
Net heart rate (HR, beats/min) at minute 20 of walking
时间窗: Minute 20 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net heart rate (HR, beats/min) at minute 10 of walking
时间窗: Minute 10 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net heart rate (HR, beats/min) at minute 15 of walking
时间窗: Minute 15 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net respiratory exchange ratio (RER, no unit) at minute 10 of walking
时间窗: Minute 10 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
时间窗: Minute 20 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net oxygen cost (OC, ml/kg/m) at minute 5 of walking
时间窗: Minute 5 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 10 of walking
时间窗: Minute 10 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 15 of walking
时间窗: Minute 15 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net oxygen cost (OC, ml/kg/m) at minute 20 of walking
时间窗: Minute 20 of 20-minute walking period
Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)
Net heart rate (HR, beats/min) at minute 5 of walking
时间窗: Minute 5 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
Net minute ventilation (VE, L/min) at minute 15 of walking
时间窗: Minute 15 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net minute ventilation (VE, L/min) at minute 10 of walking
时间窗: Minute 10 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net respiratory exchange ratio (RER, no unit) at minute 5 of walking
时间窗: Minute 5 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net minute ventilation (VE, L/min) at minute 5 of walking
时间窗: Minute 5 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net minute ventilation (VE, L/min) at minute 20 of walking
时间窗: Minute 20 of 20-minute walking period
The amount of air in- or exhaled per minute (L/min) during walking minus during rest
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking
时间窗: Minute 15 of 20-minute walking period
The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
次要结局
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking(Minute 5 of 20-minute walking period)
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking(Minute 20 of 20-minute walking period)
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking(Minute 10 of 20-minute walking period)
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking(Minute 15 of 20-minute walking period)
研究者
Nina Lefeber
Doctoral Researcher
Vrije Universiteit Brussel