Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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..
MATERIALS. A flexible facemask (adult facemask, small/medium, Cortex, Germany), lightweight chest carrying gas analysis system (Metamax 3B, Cortex, Germany) and Bluetooth heart rate belt (Polar H7, Polar Electro, Finland) will be used to measure metabolic and cardiorespiratory parameters. At the start of each measurement, gas (room air and reference gas (17.4% O2 and 5.1% CO2)) and volume (3L syringe) calibrations of the breath-by-breath gas analysis system will be performed in accordance with the manufacturer's instructions.
STATISTICAL ANALYSIS. Statistics will be performed using SPSS (IBM, Chicago, IL). The significance level will be set at 5%. Descriptive statistics will be calculated for baseline patient characteristics. Means and standard deviations will be calculated for continuous variables and frequencies and percentages for categorical variables. To investigate the effect of time and the effect of different levels of guidance force, repeated measures ANOVAs (within subject factors) will be analyzed. In case of significant differences, posthoc analysis will be interpreted. To investigate if the effect of guidance force is related to the patient's baseline level of GF (i.e. GF during regular therapy settings) correlational analysis will be performed and baseline GF will be considered as a covariate.

Conditions

Interventions

  • Regular therapy settings Other
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Lokomat training
    Description: Patients will be tested in 2 Lokomat training sessions on 2 separate days within the same week (one day in-between). During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second session patients will walk in the Lokomat with 3 different levels of guidance force.
  • Different levels of guidance force Other
    Intervention Desc: Patients will walk in the Lokomat with 3 different levels of guidance force (60%, 80% and 100%) for 10 minutes each and with the same amount of body weight support and walking speed as in the first session
    ARM 1: Kind: Experimental
    Label: Lokomat training
    Description: Patients will be tested in 2 Lokomat training sessions on 2 separate days within the same week (one day in-between). During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second session patients will walk in the Lokomat with 3 different levels of guidance force.
  • 100% guidance force Other
    Intervention Desc: Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
    ARM 1: Kind: Experimental
    Label: Lokomat training
    Description: 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).
  • 60% guidance force Other
    Intervention Desc: Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
    ARM 1: Kind: Experimental
    Label: Lokomat training
    Description: 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).

Outcomes

Type Measure Time Frame Safety Issue
Primary Oxygen consumption (VO2) End 10min resting period (separate day before the start of the sessions); begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Metabolic Equivalent of Task (MET) Begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Minute ventilation (VE) End 10min resting period (separate day before the start of the sessions); begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Heart rate (HR) End 10min resting period (separate day before the start of the sessions); begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Percentage heart rate reserve (%HRR) Begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Percentage maximal heart rate (%HRmax) Begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)
Primary Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE) End 10min resting period (separate day before the start of the sessions); begin, mid and end 30min walking period (session 1); mid, end of 10min walking periods for each %GF (session 2)

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