Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke
- Conditions
- Stroke
- Interventions
- Other: Ekso GT gait training with high swing assistanceOther: Ekso GT gait training with neutral swing assistanceOther: Ekso GT gait training with high swing resistance
- Registration Number
- NCT03367091
- Lead Sponsor
- Vrije Universiteit Brussel
- Brief Summary
To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
- Detailed Description
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%.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ekso GT gait training Ekso GT gait training with high swing assistance 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). Ekso GT gait training Ekso GT gait training with neutral swing assistance 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). Ekso GT gait training Ekso GT gait training with high swing resistance 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).
- Primary Outcome Measures
Name Time Method Net heart rate (HR, beats/min) at minute 10 of walking 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 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 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 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 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 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 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 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 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 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 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 Minute 20 of 20-minute walking period The amount of air in- or exhaled per minute (L/min) during walking minus during rest
- Secondary Outcome Measures
Name Time Method Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking Minute 5 of 20-minute walking period Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Percentage maximal heart rate (%HRmax) at minute 10 of walking Minute 10 of 20-minute walking period Heart rate divided by predicted maximum heart rate.
Percentage heart rate reserve (%HRR) at minute 20 of walking Minute 20 of 20-minute walking period Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking Minute 10 of 20-minute walking period Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking Minute 20 of 20-minute walking period Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Percentage maximal heart rate (%HRmax) at minute 20 of walking Minute 20 of 20-minute walking period Heart rate divided by predicted maximum heart rate.
Metabolic Equivalent of Task (MET) at minute 10 of walking Minute 10 of 20-minute walking period Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Percentage maximal heart rate (%HRmax) at minute 15 of walking Minute 15 of 20-minute walking period Heart rate divided by predicted maximum heart rate.
Metabolic Equivalent of Task (MET) at minute 20 of walking Minute 20 of 20-minute walking period Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Net Rating of Perceived Exertion (RPE, 6-20) at minute 15 of walking Minute 15 of 20-minute walking period Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest
Percentage heart rate reserve (%HRR) at minute 15 of walking Minute 15 of 20-minute walking period Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Metabolic Equivalent of Task (MET) at minute 5 of walking Minute 5 of 20-minute walking period Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Percentage maximal heart rate (%HRmax) at minute 5 of walking Minute 5 of 20-minute walking period Heart rate divided by predicted maximum heart rate.
Percentage heart rate reserve (%HRR) at minute 5 of walking Minute 5 of 20-minute walking period Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Percentage heart rate reserve (%HRR) at minute 10 of walking Minute 10 of 20-minute walking period Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)
Metabolic Equivalent of Task (MET) at minute 15 of walking Minute 15 of 20-minute walking period Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest
Trial Locations
- Locations (1)
REVAlution center
🇧🇪Herentals, Antwerp, Belgium