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To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke
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"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ekso GT gait training | Experimental | 20-minute Ekso GT gait training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekso GT | Device | Walking in the Ekso GT with maximum bilateral assistance for 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net oxygen cost (OC, ml/kg/m) at minute 5 of walking | Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min) | Minute 5 of 20-minute walking period |
| Net oxygen cost (OC, ml/kg/m) at minute 10 of walking | Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min) | Minute 10 of 20-minute walking period |
| Net oxygen cost (OC, ml/kg/m) at minute 15 of walking | Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min) | Minute 15 of 20-minute walking period |
| Net oxygen cost (OC, ml/kg/m) at minute 20 of walking | Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min) | Minute 20 of 20-minute walking period |
| Net heart rate (HR, beats/min) at minute 5 of walking | Heart rate during walking (beats/min) minus resting heart rate | Minute 5 of 20-minute walking period |
| Net heart rate (HR, beats/min) at minute 10 of walking | Heart rate during walking (beats/min) minus resting heart rate | Minute 10 of 20-minute walking period |
| Net heart rate (HR, beats/min) at minute 15 of walking |
| Measure | Description | Time Frame |
|---|---|---|
| Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking | Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest | Minute 5 of 20-minute walking period |
| Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed (m/min) at minute 5 of walking | The distance (meters) walked per minute | Minute 5 of 20-minute walking period |
| Walking speed (m/min) at minute 10 of walking | The distance (meters) walked per minute |
Included will be persons who
Excluded will be persons who
Can walk independently on level ground, stairs, slopes and uneven surfaces (FAC = 5)
Have musculoskeletal problems (other than stroke) affecting the ability to walk
Have concurrent pulmonary diseases (e.g. asthma)
Have unstable cardiovascular conditions
Have concurrent neurological diseases (e.g. Parkinson's Disease)
Have communicative and/or cognitive problems affecting the ability to understand or follow instructions
Present contra-indications for using the Ekso GT (according to manufacturer's instructions)
Severe concurrent medical diseases (infections, circulatory, heart or lung, pressure sores)
Severe spasticity (Ashworth 4)
Range of motion restrictions that would prevent a patient from achieving normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions
Weight ≥ 100 kg
Hip width < 35.8 cm or > 45.6 cm
Upper leg length < 51 cm or > 61.4 cm
Lower leg length < 48 cm or > 63.4 cm
Upper leg length discrepancy > 0.5 inch (1.3 cm)
Lower leg length discrepancy > 0.75 inch (1.9 cm)
Unstable spine, unhealed limbs or pelvic fractures
Unhealthy bone density
Heterotopic ossification
Significant contractures
Elbows and shoulders cannot support crutches, walker or cane
Psychiatric or cognitive situations that may interfere with proper operation of the device
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| Name | Affiliation | Role |
|---|---|---|
| Eric Kerckhofs, PhD | Vrije Universiteit Brussel | Study Chair |
| Eva Swinnen, PhD | Vrije Universiteit Brussel | Study Director |
| Nina Lefeber, PhD student | Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RevArte Rehabilitation Hospital | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Heart rate during walking (beats/min) minus resting heart rate
| Minute 15 of 20-minute walking period |
| Net heart rate (HR, beats/min) at minute 20 of walking | Heart rate during walking (beats/min) minus resting heart rate | Minute 20 of 20-minute walking period |
| Net minute ventilation (VE, L/min) at minute 5 of walking | The amount of air in- or exhaled per minute (L/min) during walking minus during rest | Minute 5 of 20-minute walking period |
| Net minute ventilation (VE, L/min) at minute 10 of walking | The amount of air in- or exhaled per minute (L/min) during walking minus during rest | Minute 10 of 20-minute walking period |
| Net minute ventilation (VE, L/min) at minute 15 of walking | The amount of air in- or exhaled per minute (L/min) during walking minus during rest | Minute 15 of 20-minute walking period |
| Net minute ventilation (VE, L/min) at minute 20 of walking | The amount of air in- or exhaled per minute (L/min) during walking minus during rest | Minute 20 of 20-minute walking period |
| Net respiratory exchange ratio (RER, no unit) at minute 5 of walking | 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 | Minute 5 of 20-minute walking period |
| Net respiratory exchange ratio (RER, no unit) at minute 10 of walking | 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 | Minute 10 of 20-minute walking period |
| Net respiratory exchange ratio (RER, no unit) at minute 15 of walking | 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 | Minute 15 of 20-minute walking period |
| Net respiratory exchange ratio (RER, no unit) at minute 15 of walking | 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 | 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 |
| Minute 10 of 20-minute walking period |
| Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking | Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest | Minute 15 of 20-minute walking period |
| Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking | Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest | Minute 20 of 20-minute walking period |
| Minute 10 of 20-minute walking period |
| Walking speed (m/min) at minute 15 of walking | The distance (meters) walked per minute | Minute 15 of 20-minute walking period |
| Walking speed (m/min) at minute 20 of walking | The distance (meters) walked per minute | Minute 20 of 20-minute walking period |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |