Status:
COMPLETED
KAFO Orthoses Versus the ABLE Exoskeleton
Lead Sponsor:
ABLE Human Motion S.L.
Collaborating Sponsors:
Hospital Asepeyo Barcelona
Biomechanical Engineering Lab (BIOMEC) - Universitat Politècnica de Catalunya (UPC)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hosp...
Detailed Description
The primary objective of this study is determining the energy efficiency through gases exchange and kinematic gait analysis to compare the standard of assistance (KAFO type orthoses) and the ABLE Exos...
Eligibility Criteria
Inclusion
- From 18 to 70 years old
- Chronic or subacute spinal cord injury.
- Currently in treatment as in-patient or ambulatory in the investigational site.
- From AIS A to AIS D with enough arm strength to withstand the bodyweight in a walking frame.
- Previous experience walking with KAFO orthoses (must tolerate standing).
- Ability to give informed consent
Exclusion
- WISCI II \>16 without the exoskeleton.
- 5 or more fragility fracture risk factors according to Craven et al.
- History of fragility fractures of lower limbs in the past 2 years.
- Deterioration \> 3 points of the total International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score within the last 4 weeks.
- Spinal instability
- Modified Ashworth scale (MAS) \> 3 in lower limbs
- Unable to tolerate 30 minutes standing without clinical symptoms of orthostatic hypotension.
- Unable to walk 5 meters with KAFO orthoses and the support of a walking frame with wheels.
- Psychological or cognitive issues that do not allow a participant to follow the study procedures.
- Any neurological condition other than SCI
- Medically unstable
- Severe comorbidities including any condition that a physician considers to not be appropriate to complete participation in the study.
- Ongoing skin issues
- Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device
- Insufficient Range of Motion (ROM) for ABLE Exoskeleton device
- Known pregnancy or breastfeeding
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04855916
Start Date
February 17 2021
End Date
September 17 2021
Last Update
October 4 2021
Active Locations (1)
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1
Hospital Asepeyo Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain, 08174