Finished
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.
Sites
- Hospital Asepeyo Sant CugatSant Cugat del Vallès, Barcelona, Spain
