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

NCT03653780 | Completed

• 1 other identifier: EKSO STUDY II
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the acute physiological responses during 20-minute overground gait training with a wearable exoskeleton in persons after stroke

Conditions

Stroke

Keywords

Wearable Exoskeleton; Stroke; Oxygen Consumption; Cardiorespiratory Responses

Outcome Measures

Primary Outcomes (16)

• 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

  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

Secondary Outcomes (4)

• Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking

  Minute 5 of 20-minute walking period

• Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking

  Minute 10 of 20-minute walking period

• Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking

  Minute 15 of 20-minute walking period

• Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking

  Minute 20 of 20-minute walking period

Other Outcomes (4)

• Walking speed (m/min) at minute 5 of walking

  Minute 5 of 20-minute walking period

• Walking speed (m/min) at minute 10 of walking

  Minute 10 of 20-minute walking period

• Walking speed (m/min) at minute 15 of walking

  Minute 15 of 20-minute walking period

Study Arms (1)

Ekso GT gait training

EXPERIMENTAL

20-minute Ekso GT gait training

Device: Ekso GT

Interventions

Ekso GT DEVICE

Walking in the Ekso GT with maximum bilateral assistance for 20 minutes

Ekso GT gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

RevArte Rehabilitation Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: August 27, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

BE (1)