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

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ClinicalTrials.gov Identifier: NCT03653780
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Lefeber, 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

Condition or disease Intervention/treatment Phase
Stroke Device: Ekso GT Not Applicable

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"

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Arm Intervention/treatment
Experimental: Ekso GT gait training
20-minute Ekso GT gait training
Device: Ekso GT
Walking in the Ekso GT with maximum bilateral assistance for 20 minutes




Primary Outcome Measures :
  1. Net oxygen cost (OC, ml/kg/m) at minute 5 of walking [ Time Frame: 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)

  2. Net oxygen cost (OC, ml/kg/m) at minute 10 of walking [ Time Frame: 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)

  3. Net oxygen cost (OC, ml/kg/m) at minute 15 of walking [ Time Frame: 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)

  4. Net oxygen cost (OC, ml/kg/m) at minute 20 of walking [ Time Frame: 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)

  5. Net heart rate (HR, beats/min) at minute 5 of walking [ Time Frame: Minute 5 of 20-minute walking period ]
    Heart rate during walking (beats/min) minus resting heart rate

  6. Net heart rate (HR, beats/min) at minute 10 of walking [ Time Frame: Minute 10 of 20-minute walking period ]
    Heart rate during walking (beats/min) minus resting heart rate

  7. Net heart rate (HR, beats/min) at minute 15 of walking [ Time Frame: Minute 15 of 20-minute walking period ]
    Heart rate during walking (beats/min) minus resting heart rate

  8. Net heart rate (HR, beats/min) at minute 20 of walking [ Time Frame: Minute 20 of 20-minute walking period ]
    Heart rate during walking (beats/min) minus resting heart rate

  9. Net minute ventilation (VE, L/min) at minute 5 of walking [ Time Frame: Minute 5 of 20-minute walking period ]
    The amount of air in- or exhaled per minute (L/min) during walking minus during rest

  10. Net minute ventilation (VE, L/min) at minute 10 of walking [ Time Frame: Minute 10 of 20-minute walking period ]
    The amount of air in- or exhaled per minute (L/min) during walking minus during rest

  11. Net minute ventilation (VE, L/min) at minute 15 of walking [ Time Frame: Minute 15 of 20-minute walking period ]
    The amount of air in- or exhaled per minute (L/min) during walking minus during rest

  12. Net minute ventilation (VE, L/min) at minute 20 of walking [ Time Frame: Minute 20 of 20-minute walking period ]
    The amount of air in- or exhaled per minute (L/min) during walking minus during rest

  13. Net respiratory exchange ratio (RER, no unit) at minute 5 of walking [ Time Frame: 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

  14. Net respiratory exchange ratio (RER, no unit) at minute 10 of walking [ Time Frame: 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

  15. Net respiratory exchange ratio (RER, no unit) at minute 15 of walking [ Time Frame: Minute 15 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

  16. Net respiratory exchange ratio (RER, no unit) at minute 15 of walking [ Time Frame: 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


Secondary Outcome Measures :
  1. Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking [ Time Frame: 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

  2. Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking [ Time Frame: 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

  3. Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking [ Time Frame: 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

  4. Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking [ Time Frame: 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


Other Outcome Measures:
  1. Walking speed (m/min) at minute 5 of walking [ Time Frame: Minute 5 of 20-minute walking period ]
    The distance (meters) walked per minute

  2. Walking speed (m/min) at minute 10 of walking [ Time Frame: Minute 10 of 20-minute walking period ]
    The distance (meters) walked per minute

  3. Walking speed (m/min) at minute 15 of walking [ Time Frame: Minute 15 of 20-minute walking period ]
    The distance (meters) walked per minute

  4. Walking speed (m/min) at minute 20 of walking [ Time Frame: Minute 20 of 20-minute walking period ]
    The distance (meters) walked per minute



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Included will be persons who

  • Had a stroke (1 week to 6 months since injury)
  • Are 18 years or older
  • Cannot walk independently or can walk independently on level ground, but require help on stairs, slopes or uneven surfaces (FAC 0 - 4)
  • Have prior experience with the Ekso GT (i.e. 4 training sessions)

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

      • Bilateral hip flexion < 110°
      • Knee flexion contracture > 12°
      • Inability to achieve 0° neutral angle dorsiflexion with knee flexion ≤ 12°
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653780


Locations
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Belgium
RevArte Rehabilitation Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
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Study Chair: Eric Kerckhofs, PhD Vrije Universiteit Brussel
Study Director: Eva Swinnen, PhD Vrije Universiteit Brussel
Principal Investigator: Nina Lefeber, PhD student Vrije Universiteit Brussel
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Responsible Party: Nina Lefeber, Doctoral Researcher, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03653780    
Other Study ID Numbers: EKSO STUDY II
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nina Lefeber, Vrije Universiteit Brussel:
Wearable Exoskeleton
Stroke
Oxygen Consumption
Cardiorespiratory Responses
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases