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KAFO Orthoses Versus the ABLE Exoskeleton

NCT04855916 · ABLE Human Motion S.L. · Updated 4 Oct 2021

What is being tested
ABLE Exoskeleton; KAFO Orthosis
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 10 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 17 Feb 2021, ends 17 Sept 2021. Registered 22 April 2021.
Results
None posted yet.

In the researchers' words

This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting. The ABLE Exoskeleton is a robotic exoskeleton that actively assists individuals with mobility problems to stand up, walk and sit down. The main objective of the study is to compare the energy efficiency during gait with both devices. Secondary objectives are: compare gait kinematics, usability, user's satisfaction, physical activity and psychosocial impact. The study will also serve to evaluate the usability and safety of the ABLE Exoskeleton in clinical practice. Subjects will complete 10 gait training sessions during a 5-week period with 1 of the 2 devices randomly selected, followed by a post-training assessment consisting of 1 session. Once the test is completed, subjects will have a 2-week rest period after which they will repeat the process with the other device for 5 weeks (followed by 1 post-training assessment session). The study will be conducted at Hospital Asepeyo Barcelona in Spain, where a total of 10 patients will be recruited.
ClinicalTrials.gov, NCT04855916

Sites

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