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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE August 27, 2018
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2018)
  • Walking speed (m/min) at minute 5 of walking [ Time Frame: Minute 5 of 20-minute walking period ]
    The distance (meters) walked per minute
  • Walking speed (m/min) at minute 10 of walking [ Time Frame: Minute 10 of 20-minute walking period ]
    The distance (meters) walked per minute
  • Walking speed (m/min) at minute 15 of walking [ Time Frame: Minute 15 of 20-minute walking period ]
    The distance (meters) walked per minute
  • Walking speed (m/min) at minute 20 of walking [ Time Frame: Minute 20 of 20-minute walking period ]
    The distance (meters) walked per minute
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
Official Title  ICMJE Physiological Responses During Overground Gait Training With a Wearable Exoskeleton After Stroke
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"

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Stroke
Intervention  ICMJE Device: Ekso GT
Walking in the Ekso GT with maximum bilateral assistance for 20 minutes
Study Arms  ICMJE Experimental: Ekso GT gait training
20-minute Ekso GT gait training
Intervention: Device: Ekso GT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653780
Other Study ID Numbers  ICMJE EKSO STUDY II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nina Lefeber, Vrije Universiteit Brussel
Study Sponsor  ICMJE Vrije Universiteit Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Vrije Universiteit Brussel
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP