Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
- Conditions
- Stroke
- Interventions
- Device: Ekso GT
- Registration Number
- NCT03653780
- Lead Sponsor
- Vrije Universiteit Brussel
- Brief Summary
To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke
- Detailed Description
STUDY DESIGN: An experimental, 1-group trial
PATIENT RECRUITMENT: A minimum of 10 subjects will be included in the study. Patients will be recruited at the Revarte Rehabilitation Hospital (Edegem, Belgium).
ELIGIBILITY CRITERIA: see section "Eligibility"
PROCEDURES: The trial will be conducted at the Revarte Rehabilitation Hospital (Edegem, Belgium).
Before the start of the study, informed consent and baseline patient characteristics will be collected.
On a separate day before the start of the 5th training session, patients will be seated for 5 minutes during which resting values (respiratory gases and heart rate) will be assessed.
Next, participants will be measured during their 5th training session with the Ekso GT with maximum bilateral assistance. Following settings will be used: sitting program ("Min lean"); standing program ("Auto lean"); step initiation program ("ProStep+"), training mode ("Both"), assistance mode ("Bilat"), swing assistance ("Max"), stance support ("Full").
At the start of the 5th training, 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 total of 20 minutes during which respiratory gases and heart rate will be monitored continuously. The Borg rating of perceived exertion will be registered every 5 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.
During training, patients will walk at a self-selected walking speed.
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: During the overground gait training sessions, the Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be used. 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"
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ekso GT gait training Ekso GT 20-minute Ekso GT gait training
- 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 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 respiratory exchange ratio (RER, no unit) at minute 10 of walking Minute 10 of 20-minute walking period The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
Net respiratory exchange ratio (RER, no unit) at minute 15 of walking Minute 20 of 20-minute walking period The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at 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 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 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 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 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 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 respiratory exchange ratio (RER, no unit) at minute 5 of walking Minute 5 of 20-minute walking period The ratio between the amount of CO2 produced by the body and the amount of VO2 consumed by the body minus the ratio at rest
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 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
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
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
Trial Locations
- Locations (1)
RevArte Rehabilitation Hospital
🇧🇪Edegem, Antwerp, Belgium