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临床试验/NCT03367091
NCT03367091终止不适用

Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Net heart rate (HR, beats/min) 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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ekso GT gait training

Experimental

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

Experimental

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

Experimental

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 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 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 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 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 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 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)
  • Net Rating of Perceived Exertion (RPE, 6-20) at minute 15 of walking(Minute 15 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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Lefeber

Doctoral Researcher

Vrije Universiteit Brussel

研究点 (2)

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