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
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): ABLE Exoskeleton
Intervention type(s): Device
Intervention description(s): The ABLE Exoskeleton is a lower-limb overground robotic exoskeleton intended for SCI patients for rehabilitation in a clinical setting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Spinal Cord Injury; Exoskeleton; Robotics; Gait; Rehabilitation; Lower-limb; Neurorehabilitation; Paraplegia; Walking; Assistive technology; Usability; Safety; Feasibility; Multicenter