Clinical Investigation on Safety, Feasibility and Usability of the 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 (9 kg) and easier to use.

      The primary objective of the study is to investigate the safety, feasibility and usability of
      the ABLE exoskeleton device in people with spinal cord injury during a four to six weeks gait
      training in clinical settings. 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 safety, feasibility, and usability of
      using the ABLE Exoskeleton for patients with SCI in a hospital setting during a 4-6 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.

        -  Assess the psychosocial impact of the ABLE Exoskeleton for participants

      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
      three times a week for four weeks for a total of 12 sessions. Standardized clinical
      assessments with the device will be performed during the first and the last training
      sessions. During the training period, several safety and usability measurements will be
      taken. After the last training session, baseline assessments without the exoskeleton will be
      repeated during a post-study assessment. Four 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.

      This is the first study investigating the use of the ABLE Exoskeleton, therefore the primary
      hypothesis of this study is that the ABLE Exoskeleton is safe, feasible, and usable for the
      intended patient population with SCI in a hospital setting. The secondary hypothesis is that
      the device will have a positive impact on the perceived rate of exertion, mobility, and
      psychosocial health of the study participants with SCI.
    

Intervention name(s): ABLE Exoskeleton
Intervention type(s): Device
Intervention description(s): Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Exoskeleton; Robotics; Gait; Rehabilitation; Lower-limb; Neurorehabilitation; Paraplegia; Walking; Assistive technology; Usability; Safety; Feasibility; Multicenter