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

Investigación Clínica Sobre el Impacto en la Seguridad, Viabilidad y Usabilidad de Los Cambios de diseño Realizados en el Dispositivo ABLE Exoskeleton en Pacientes Con lesión Medular en un Entorno Hospitalario

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: ABLE Human Motion S.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this study is to determine the impact of the performed design changes on safety, feasibility, and usability of the ABLE Exoskeleton for patients with SCI in a hospital setting during a 5-6 week training programme. The secondary objectives are as follows: * Assess the impact of ABLE Exoskeleton training on gait and function. * Assess the effect on the perceived rate of exertion for patients using the ABLE Exoskeleton. * Assess the level of user satisfaction from participants and therapists of the ABLE Exoskeleton. Patients who match inclusion and exclusion criteria and pass pre-study screening will be enrolled in the study. Following the screening, baseline assessments will be conducted without the device. Participants will undergo a training programme with the ABLE Exoskeleton two times a week for five weeks for a total of 10 sessions. Standardized clinical assessments with the device will be performed during the last training sessions. During the training period, several safety and usability measurements will be taken. Two weeks after the final training session a follow-up assessment will be conducted with participants. At the end of the study, the participating therapists will be asked to fill out a satisfaction questionnaire. The primary hypothesis of this study is that the ABLE Exoskeleton remains safe, feasible, and usable for the intended patient population with SCI in a hospital setting after the implementation of the design changes improving its performance. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility, and level of satisfaction of the study participants with SCI.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	ABLE Exoskeleton	The ABLE Exoskeleton is a lower-limb overground robotic exoskeleton intended for SCI patients for rehabilitation in a clinical setting.

Timeline

• Start date: 2022-10-19
• Primary completion: 2023-01-16
• Completion: 2023-01-16
• First posted: 2022-10-21
• Last updated: 2023-04-07

Locations

1 site across 1 country: Spain