Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke

NCT03367091 | Terminated

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

Brief Summary

To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke

Conditions

Stroke

Keywords

Wearable Exoskeleton; Stroke; Energy Consumption; Cardiorespiratory Load

Outcome Measures

Primary Outcomes (12)

• 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

Secondary Outcomes (16)

• 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 15 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

• Percentage maximal heart rate (%HRmax) at minute 5 of walking

  Minute 5 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

Participants will be measured during three Ekso GT gait trainings: * 20-minute Ekso GT gait training with high swing assistance * 20-minute Ekso GT gait training with neutral swing assistance * 20-minute Ekso GT gait training with high swing resistance. Each training will be performed on a separate day in a randomized order (within one week and controlled for time of day).

Other: Ekso GT gait training with high swing assistance; Other: Ekso GT gait training with neutral swing assistance; Other: Ekso GT gait training with high swing resistance

Interventions

Ekso GT gait training with high swing assistance OTHER

Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high assistance"

Ekso GT gait training

Ekso GT gait training with neutral swing assistance OTHER

Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "neutral"

Ekso GT gait training

Ekso GT gait training with high swing resistance OTHER

Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high resistance"

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 * Cannot walk independently or can walk independently on level ground, but still require help on stairs, slopes or uneven surfaces (FAC 0 - 4) 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 are unable to 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)

REVAlution center

Herentals, Antwerp, 2200, 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, Prof, PhD

  Vrije Universiteit Brussel

  STUDY CHAIR

• Eva Swinnen, Prof, 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: November 30, 2017
• First Posted: December 8, 2017
• Study Start: July 9, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

BE (1)