NCT03653780

Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vrije Universiteit Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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"

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Ekso GT	Walking in the Ekso GT with maximum bilateral assistance for 20 minutes

Timeline

• Start date: 2018-08-27
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-08-31
• Last updated: 2019-02-06

Locations

1 site across 1 country: Belgium