Stroke Clinical Trial
Official title:
Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
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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