NCT05643313

Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills in home and community environments.

Detailed description

The primary objective of this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills for home and community environments during a training programme of up to 8 weeks. Results will be used to assess the potential of the device to be used in a home and community setting by persons with SCI, while providing meaningful insights to develop future features to improve its performance in those environments. The secondary objectives are as follows: * Assess the impact of ABLE Exoskeleton training on gait and function. * Assess the effect of the ABLE Exoskeleton on the patients' perceived rate of exertion. * Assess the impact of the ABLE Exoskeleton on the quality of life and general health of the participants. * Assess the level of user satisfaction from participants and therapists of the ABLE Exoskeleton. * Assess the psychosocial impact of the ABLE Exoskeleton for participants. The primary hypothesis of this study is that the ABLE Exoskeleton is feasible to be used by persons with SCI to perform skills for home and community environments. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility and psychosocial health, and quality of life and general health of the study participants with SCI. This is a multicenter pre-post quasi-experimental study. The pre-post period will cover 22 exoskeleton sessions (18 training sessions and 4 assessment sessions) over a period of up to 8 weeks. The study will have two centres specialized in SCI involved, one at Heidelberg University, Germany and another at Institut Guttmann, Spain. In total 10 patients will be recruited. After obtaining a Patient Information Sheet and Informed Consent Form (PIS/ICF), patients will be screened. Patients who match inclusion and exclusion criteria and pass pre-study screening, will be enrolled into the study. First, there will be a familiarisation session (session 0), where participants will learn how to use the device. Participants will then undergo a training programme with the ABLE Exoskeleton three to five times a week for up to 8 weeks for a total of 18 training sessions and 4 assessment sessions. The assessment sessions with the device will be performed at 4 time-points throughout training: Baseline (Session 1), Mid-training (Session 11), Final-training (Session 21) and Home-Skills-Test (Session 22). This therefore means there will be a total of 22 exoskeleton sessions, including training and assessments. During each training session, feasibility measurements will be taken via the evaluation of the performance of exoskeleton skills. Four weeks after the post-training assessment, 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.

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: 2022-11-25
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2022-12-08
• Last updated: 2023-10-19

Locations

2 sites across 2 countries: Germany, Spain