Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton device with spinal cord injured patients in a hospital setting

Not Applicable

• Conditions: G82; Paraplegia and tetraplegia

• Registration Number: DRKS00023503
• Lead Sponsor: ABLE Human Motion S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study Completion: 2021-11-26
• Results First Posted: 2023-04-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

? 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 Criteria

? 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For safety the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.<br><br>Feasibility and usability of the device will be assessed by: Level of Assistance (LoA) and time taken to don/doff the device; LoA to complete therapy activity tasks; Number of steps, walking time and standing time.