Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description

The primary objective of this study is determining the energy efficiency through gases exchange and kinematic gait analysis to compare the standard of assistance (KAFO type orthoses) and the ABLE Exoskeleton, a robotic gait assistance device, in patients with spinal cord injury (SCI) in a hospital setting. The secondary objectives are to compare the performance of KAFO-type orthoses with that of the ABLE Exoskeleton device by: - Kinematic analysis of gait and spatiotemporal gait parameters. - Evaluation of the time and effort required to learn to use the device (usability). - Evaluation of the impact that physical activity has on participants after gait training. - Evaluation of the level of satisfaction of the participants. In addition to these objectives, the safety of the ABLE Exoskeleton as an assistive device for gait rehabilitation in SCI patients will be evaluated throughout the study. Participants will perform 2 training sessions per week of approximately 90 minutes duration for 5 weeks with each of the devices, completing a total of 10 sessions with KAFO type orthoses and 10 sessions with the ABLE Exoskeleton. Before starting the training period, the physical capacity of the participants will be measured. During the training period sessions, different measurements of the level of assistance, spatiotemporal gait variables and usability will be taken. Standardized clinical assessments will also be performed during sessions 5 and 10 (assessment sessions). At the end of the training period, a post-training assessment will be performed, consisting of 1 session where the physical capacity of the participants will be measured. After finishing the training period with one of the devices, participants will have a rest period of 2 weeks, after which they will change devices and repeat the whole process. The main hypothesis of the study is that gait efficiency in patients with SCI is improved (lower energy consumption) when using the ABLE Exoskeleton device in comparison with KAFO-type orthoses. The increase in gait efficiency encourages patients to stand and walk for longer periods instead of using the wheelchair, which boosts their rehabilitation and improves their health. Secondary hypotheses are: - The ABLE Exoskeleton device will improve the kinematics and spatiotemporal parameters of gait (more closely resemble the gait pattern of a healthy individual), relative to KAFO-type orthoses. - The ABLE Exoskeleton device will have a more positive impact on the mobility and psychosocial health of participants with SCI in the study, with respect to KAFO-type orthoses. - The ABLE Exoskeleton device is a safe device to use in a hospital setting as an assistive device during gait rehabilitation in SCI patients. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04855916
Study type Interventional
Source ABLE Human Motion S.L.
Contact Anna Mas Vinyals, PhD
Phone +34 678246149
Email [email protected]
Status Recruiting
Phase N/A
Start date February 17, 2021
Completion date September 17, 2021

See also
  Status Clinical Trial Phase
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT04458324 - Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury Phase 2
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Enrolling by invitation NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Recruiting NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Completed NCT03859960 - The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury
Recruiting NCT03576001 - Multimodality Intervention for Function and Metabolism in SCI Phase 2
Not yet recruiting NCT04390087 - Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users N/A
Not yet recruiting NCT04465825 - Developing Strategies to Optimize the Exercise Response After Tetraplegia. N/A
Recruiting NCT02923817 - Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury Phase 2
Completed NCT03284086 - VO2peak and Exercise Efficiency in Upper-body Poling N/A
Completed NCT03025048 - A Holistic Dietary Intervention for Persons With Spinal Cord Injury
Completed NCT02099357 - Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training N/A
Terminated NCT02230540 - Intermittent Catheterization in Spinal Cord Injured Men N/A