Stroke Clinical Trial
Official title:
Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance
To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
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).
ELIGIBILITY CRITERIA: See section "Eligibility"
PROCEDURES: Before the start of the study, informed consent and baseline patient
characteristics will be collected. Next, participants will be measured during three training
sessions with the Ekso GT SmartAssist:
- 20-minute training with high swing assistance
- 20-minute training with neutral swing assistance
- 20-minute training with high swing resistance
Trainings will be performed on a separate day in a randomized order (within one week and
controlled for time of day).
Following settings will be used in all three conditions: sitting program ("Min lean");
standing program ("Auto lean"); step initiation program ("ProStep+"), training mode ("Off"),
SmartAssist option ("2Free"); and stance support ("Low"). The level of stance support and
swing assistance will be set symmetrically for the affected and non-affected side.
During training, participants will walk back and forth at a self-selected walking speed in a
30m hall way using a cane at the non-affected side.
Prior to the experimental conditions, participants will have had three training sessions in
the Ekso GT.
RESTRICTIONS & PROHIBITIONS: Participants 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.
MATERIALS: The Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be
used during the overground training sessions.
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.
OUTCOMES: See section "Outcome Measures"
DATA-ANALYSES: Descriptive statistics will be calculated for baseline patient
characteristics. To investigate the effect of level of swing assistance and duration, a
repeated measures ANOVA (within factor duration and within factor assistance level) will be
conducted (interaction-effect time x duration, main effect assistance level and main effect
duration). In case of significant differences, posthoc analyses will be interpreted. The
walking speed will be considered as a covariate in the ANOVA analysis (in case significant
different between conditions). Significance level will be set at 5%.
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