Stroke Clinical Trial
Official title:
Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients
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.
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.
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