Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Net oxygen cost (OC, ml/kg/m) at minute 10 of walking
研究概览
简要总结
To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
详细描述
RESEARCH AIMS:
- To investigate the effect of the level of swing assistance on the acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
- To investigate if there is an interaction-effect between the level of swing assistance and the duration of walking
- To compare the exercise intensity to aerobic training recommendations
STUDY DESIGN: An experimental, 1-group trial with randomized crossover design.
PATIENT RECRUITMENT: Participants will be recruited at the AZ Herentals (Herentals, Belgium).
LOCATION: The trial will be conducted at the REVAlution Center (Herentals, Belgium).
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
- •Cannot walk independently or can walk independently on level ground, but still require help on stairs, slopes or uneven surfaces (FAC 0 - 4)
- •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 are unable to 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
Participants will be measured during three Ekso GT gait trainings:
- 20-minute Ekso GT gait training with high swing assistance
- 20-minute Ekso GT gait training with neutral swing assistance
- 20-minute Ekso GT gait training with high swing resistance.
Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day).
干预措施: Ekso GT gait training with high swing assistance (Other)
Ekso GT gait training
Participants will be measured during three Ekso GT gait trainings:
- 20-minute Ekso GT gait training with high swing assistance
- 20-minute Ekso GT gait training with neutral swing assistance
- 20-minute Ekso GT gait training with high swing resistance.
Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day).
干预措施: Ekso GT gait training with neutral swing assistance (Other)
Ekso GT gait training
Participants will be measured during three Ekso GT gait trainings:
- 20-minute Ekso GT gait training with high swing assistance
- 20-minute Ekso GT gait training with neutral swing assistance
- 20-minute Ekso GT gait training with high swing resistance.
Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day).
干预措施: Ekso GT gait training with high swing resistance (Other)
结局指标
主要结局
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 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 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 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 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 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 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 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 15 of walking
时间窗: Minute 15 of 20-minute walking period
Heart rate during walking (beats/min) minus resting heart rate
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 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 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
次要结局
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 15 of walking(Minute 15 of 20-minute walking period)
- Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking(Minute 5 of 20-minute walking period)
- Percentage maximal heart rate (%HRmax) at minute 10 of walking(Minute 10 of 20-minute walking period)
- Percentage heart rate reserve (%HRR) 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 20 of 20-minute walking period)
- Percentage maximal heart rate (%HRmax) at minute 20 of walking(Minute 20 of 20-minute walking period)
- Metabolic Equivalent of Task (MET) at minute 10 of walking(Minute 10 of 20-minute walking period)
- Percentage maximal heart rate (%HRmax) at minute 15 of walking(Minute 15 of 20-minute walking period)
- Metabolic Equivalent of Task (MET) at minute 20 of walking(Minute 20 of 20-minute walking period)
- Percentage heart rate reserve (%HRR) at minute 15 of walking(Minute 15 of 20-minute walking period)
- Metabolic Equivalent of Task (MET) at minute 5 of walking(Minute 5 of 20-minute walking period)
- Percentage maximal heart rate (%HRmax) at minute 5 of walking(Minute 5 of 20-minute walking period)
- Percentage heart rate reserve (%HRR) at minute 5 of walking(Minute 5 of 20-minute walking period)
- Percentage heart rate reserve (%HRR) at minute 10 of walking(Minute 10 of 20-minute walking period)
- Metabolic Equivalent of Task (MET) at minute 15 of walking(Minute 15 of 20-minute walking period)
研究者
Nina Lefeber
Doctoral Researcher
Vrije Universiteit Brussel