Status:
TERMINATED
Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke
Lead Sponsor:
Vrije Universiteit Brussel
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke
Detailed Description
RESEARCH AIMS: * To investigate the effect of the level of swing assistance on the acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in perso...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03367091
Start Date
July 9 2018
End Date
December 31 2018
Last Update
February 7 2019
Active Locations (1)
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1
REVAlution center
Herentals, Antwerp, Belgium, 2200