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Clinical Investigation on the Impact on Safety, Feasibility and Usability of the Design Changes Performed on ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting

NCT05590065 · ABLE Human Motion S.L. · Updated 7 April 2023

What is being tested
ABLE Exoskeleton
For
Spinal Cord Injuries
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 70 years. About 5 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 19 Oct 2022, ends 16 Jan 2023. Registered 21 Oct 2022.
Results
None posted yet.

In the researchers' words

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 technology has the potential to help people with impaired leg function to regain ambulation and thus improve their independence. This technology is not completely new, but due to their high access price (\~120k€/unit), high size and weight (\~25 kg), and need for trained physiotherapist supervision, commercially available exoskeletons are only found in large hospitals and only in very few cases get into patients' homes. The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter and easier to use. The primary objective of the study is to investigate the impact of recent design changes performed on the device on the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a five to six weeks gait training programme in a clinical setting. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.
ClinicalTrials.gov, NCT05590065

Sites

  • Hospital Asepeyo Sant CugatSant Cugat del Vallès, Barcelona, Spain