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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03367091
Date of registration:	30/11/2017
Prospective Registration:	Yes
Primary sponsor:	Vrije Universiteit Brussel
Public title:	Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke
Scientific title:	Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance
Date of first enrolment:	July 9, 2018
Target sample size:	1
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT03367091
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Eric Kerckhofs, Prof, PhD
Address:
Telephone:
Email:
Affiliation:	Vrije Universiteit Brussel

Name:	Nina Lefeber, PhD student
Address:
Telephone:
Email:
Affiliation:	Vrije Universiteit Brussel

Name:	Eva Swinnen, Prof, PhD
Address:
Telephone:
Email:
Affiliation:	Vrije Universiteit Brussel

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Other: Ekso GT gait training with neutral swing assistance

Other: Ekso GT gait training with high swing assistance

Other: Ekso GT gait training with high swing resistance

Primary Outcome(s)

Net heart rate (HR, beats/min) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Net oxygen cost (OC, ml/kg/m) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Net minute ventilation (VE, L/min) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

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

Net minute ventilation (VE, L/min) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Net oxygen cost (OC, ml/kg/m) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Net minute ventilation (VE, L/min) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

Net oxygen cost (OC, ml/kg/m) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

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

Net minute ventilation (VE, L/min) at minute 10 of walking [Time Frame: Minute 10 of 20-minute walking period]

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

Net oxygen cost (OC, ml/kg/m) at minute 10 of walking [Time Frame: Minute 10 of 20-minute walking period]

Secondary Outcome(s)

Metabolic Equivalent of Task (MET) at minute 10 of walking [Time Frame: Minute 10 of 20-minute walking period]

Percentage heart rate reserve (%HRR) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Metabolic Equivalent of Task (MET) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Percentage heart rate reserve (%HRR) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

Metabolic Equivalent of Task (MET) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

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

Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

Percentage maximal heart rate (%HRmax) at minute 10 of walking [Time Frame: Minute 10 of 20-minute walking period]

Percentage maximal heart rate (%HRmax) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Metabolic Equivalent of Task (MET) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Percentage heart rate reserve (%HRR) at minute 10 of walking [Time Frame: Minute 10 of 20-minute walking period]

Net Rating of Perceived Exertion (RPE, 6-20) at minute 15 of walking [Time Frame: Minute 15 of 20-minute walking period]

Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Percentage heart rate reserve (%HRR) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Percentage maximal heart rate (%HRmax) at minute 5 of walking [Time Frame: Minute 5 of 20-minute walking period]

Percentage maximal heart rate (%HRmax) at minute 20 of walking [Time Frame: Minute 20 of 20-minute walking period]

Secondary ID(s)

EKSO STUDY I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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