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
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and 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 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.
    

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; Feasibility; Home use; Community use; Multicenter