Status:
COMPLETED
Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Lead Sponsor:
ABLE Human Motion S.L.
Collaborating Sponsors:
Institut Guttmann
Heidelberg University Hospital Spinal Cord Injury Center
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians. Exoskeletal...
Detailed Description
The primary objective of this study is to determine the safety, feasibility, and usability of using the ABLE Exoskeleton for patients with SCI in a hospital setting during a 4-6 week training programm...
Eligibility Criteria
Inclusion
- 18 to 70 years of age
- Traumatic and non-traumatic SCI
- Currently receiving treatment as an inpatient or outpatient at one of the investigational sites
- AIS A to AIS D with sufficient arm strength to support body weight on a walking frame
- Ability to give informed consent
Exclusion
- WISCI II without exoskeleton of \>16
- 5 or more risk factors for fragility as stated by Craven et al (29)
- History of lower limb fragility fractures in the last 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 min standing without clinical symptoms of orthostatic hypotension
- Unable to perform a sit-to-stand transfer or stand in the device with assistance
- 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 :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04876794
Start Date
November 3 2020
End Date
November 19 2021
Last Update
January 14 2022
Active Locations (2)
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1
Spinal Cord Injury Center | Heidelberg University Hospital
Heidelberg, Germany, 69118
2
Institut Guttmann
Badalona, Barcelona, Spain, 08916