NCT05590065

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

Completed NA Last updated 7 April 2023

What this trial tests

NA trial testing ABLE Exoskeleton in Spinal Cord Injuries in 5 participants. Completed in 16 January 2023.

Timeline

19 October 2022

Primary endpoint
16 January 2023

16 January 2023

Quick facts

Lead sponsor	ABLE Human Motion S.L.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	5
Start date	19 October 2022
Primary completion	16 January 2023
Estimated completion	16 January 2023
Sites	1 location across Spain

Drugs / interventions tested

• ABLE Exoskeleton

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

ABLE Human Motion S.L.

Who can join

Adults 18 to 70, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing exoskeleton technology through co-creation with clinicians and patients: a pilot study and comparative analysis of the ABLE exoskeleton.
   Porras-Martínez E, Kreamer-Tonin K, Lobo-Prat J, López-Matas H, et al · · 2025 · PMID 40331262 · DOI 10.1080/09638288.2025.2496351
2. Safety, performance and user satisfaction study of the new ABLE lower-limb exoskeleton for individuals with SCI: the result of a co-creation process with clinicians and patients
   Porras-Martínez E, López-Matas H, Lobo-Prat J, Kreamer-Tonin K, et al · · 2023 · DOI 10.21203/rs.3.rs-3199890/v1