Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Oxygen consumption (VO2)
研究概览
简要总结
The aim of this study will be to investigate the energy consumption, cardiorespiratory load and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted gait training (RAGT) session and to compare the exercise intensity with aerobic training recommendations.
The second aim is to investigate the effect of different levels of guidance force on the energy consumption, cardiorespiratory load and perceived exertion.
详细描述
STUDY DESIGN. An experimental, 1-group, single-centre trial will be conducted in which stroke patients will perform 2 RAGT sessions: 1) walking in the Lokomat according to regular RAGT settings and 2) walking in the Lokomat with different levels of guidance force (60%, 80% and 100%).
PATIENT RECRUITMENT. We aim to recruit 20 stroke patients in the St. Ursula Rehabilitation Centre in Herk-de-Stad, Belgium.
RESTRICTIONS AND PROHIBITIONS. Patients will be instructed to not consume food, alcohol, caffeine or nicotine at least 3h prior to the intervention. Usual medication intake will be allowed with small amounts of water.
PROCEDURE. Patients will be tested in 3 RAGT sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed). During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (once 60% and once 100%) for a minimum 20 minutes each and with the same amount of body weight support and walking speed as in the first session. On a separate day before the intervention, patients will be seated for 10 minutes during which resting values (respiratory gases and heart rate) will be assessed (in order to measure their Resting Metabolic Rate). In addition, informed consent and baseline clinical demographic characteristics will be obtained. At the start of the intervention, a mouth mask, heart rate monitor and gait analysis system will be applied. After a seated resting period of 5 minutes, patients will walk for a minimum of 20 minutes during which respiratory gases and heart rate will be monitored continuously. The Borg rating of perceived exertion will be registered every 3 minutes. The intervention will be terminated early when relative or absolute indications are presented as reported by the American Heart Association or when patients are unable to continue walking. Walking sessions will be controlled for time of day.
RANDOMIZATION. The levels of GF will be randomised..
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
- •First-ever subacute (≤ 3 months) stroke patients
- •Eligible to receive robot-assisted gait training according to local therapists' criteria (i.e. non-ambulatory stroke patients that are able to bear full weight on the hemiplegic leg during a minimum of one gait cycle with manual help allowed to maintain balance)
- •Functional Ambulation Category < 3
- •Trained in the Lokomat system 2 times prior to the start of the study (i.e. one fitting session and one training session).
排除标准
- •> 135 kg and >179 cm
- •Unstable cardiovascular conditions
- •Musculoskeletal problems (other than stroke) affecting the ability to walk
- •Concurrent pulmonary diseases (e.g. asthma)
- •Concurrent neurological diseases
- •Communicative and/or cognitive problems affecting the ability to comprehend or follow instructions
- •Other problems affecting the execution of the intervention (e.g. severe spasticity, contractures or dermatological contra-indications)
研究组 & 干预措施
Lokomat training
Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).
干预措施: Regular therapy settings (Device)
Lokomat training
Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).
干预措施: 100% guidance force (Device)
Lokomat training
Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).
干预措施: 60% guidance force (Device)
结局指标
主要结局
Oxygen consumption (VO2)
时间窗: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
Average oxygen consumption (mL/kg/min) at different time frames. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Carbon Dioxide Production (CO2)
时间窗: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
Average carbon dioxide production (mL/kg/min) at different time frames. Carbon dioxide production will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
Heart rate (HR)
时间窗: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
Average heart rate (beats/min) at different time frames. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Percentage maximal heart rate (%HRmax)
时间窗: Begin, mid and end of 20min walking period (session 1)
The percentage of the person's predicted maximal heart rate at different time moments (= heart rate at different times moments divided by predicted maximal heart rate).
Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE)
时间窗: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) at the end of rest and during walking (every 3 minutes).
Minute ventilation (VE)
时间窗: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
Average amount of air in- or exhaled (L/min) at different time frames. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
Percentage heart rate reserve (%HRR)
时间窗: Begin, mid and end of 20min walking period (session 1)
The percentage of the heart rate reserve (i.e. the difference between the person's predicted maximum heart rate and the person's resting heart rate) at different time moments (= heart rate at different times moments divided by predicted heart rate reserve).
次要结局
未报告次要终点
研究者
Nina Lefeber
Doctoral Researcher
Vrije Universiteit Brussel