KAFO Orthoses Versus the ABLE Exoskeleton
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This randomized crossover study will compare walking with KAFO type orthoses (current
      standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal
      cord injury in a hospital setting. The ABLE Exoskeleton is a robotic exoskeleton that
      actively assists individuals with mobility problems to stand up, walk and sit down.

      The main objective of the study is to compare the energy efficiency during gait with both
      devices. Secondary objectives are: compare gait kinematics, usability, user's satisfaction,
      physical activity and psychosocial impact. The study will also serve to evaluate the
      usability and safety of the ABLE Exoskeleton in clinical practice.

      Subjects will complete 10 gait training sessions during a 5-week period with 1 of the 2
      devices randomly selected, followed by a post-training assessment consisting of 1 session.
      Once the test is completed, subjects will have a 2-week rest period after which they will
      repeat the process with the other device for 5 weeks (followed by 1 post-training assessment
      session). The study will be conducted at Hospital Asepeyo Barcelona in Spain, where a total
      of 10 patients will be recruited.
    

Detailed description: 
      The primary objective of this study is determining the energy efficiency through gases
      exchange and kinematic gait analysis to compare the standard of assistance (KAFO type
      orthoses) and the ABLE Exoskeleton, a robotic gait assistance device, in patients with spinal
      cord injury (SCI) in a hospital setting.

      The secondary objectives are to compare the performance of KAFO-type orthoses with that of
      the ABLE Exoskeleton device by:

        -  Kinematic analysis of gait and spatiotemporal gait parameters.

        -  Evaluation of the time and effort required to learn to use the device (usability).

        -  Evaluation of the impact that physical activity has on participants after gait training.

        -  Evaluation of the level of satisfaction of the participants.

      In addition to these objectives, the safety of the ABLE Exoskeleton as an assistive device
      for gait rehabilitation in SCI patients will be evaluated throughout the study.

      Participants will perform 2 training sessions per week of approximately 90 minutes duration
      for 5 weeks with each of the devices, completing a total of 10 sessions with KAFO type
      orthoses and 10 sessions with the ABLE Exoskeleton. Before starting the training period, the
      physical capacity of the participants will be measured. During the training period sessions,
      different measurements of the level of assistance, spatiotemporal gait variables and
      usability will be taken. Standardized clinical assessments will also be performed during
      sessions 5 and 10 (assessment sessions). At the end of the training period, a post-training
      assessment will be performed, consisting of 1 session where the physical capacity of the
      participants will be measured. After finishing the training period with one of the devices,
      participants will have a rest period of 2 weeks, after which they will change devices and
      repeat the whole process.

      The main hypothesis of the study is that gait efficiency in patients with SCI is improved
      (lower energy consumption) when using the ABLE Exoskeleton device in comparison with
      KAFO-type orthoses. The increase in gait efficiency encourages patients to stand and walk for
      longer periods instead of using the wheelchair, which boosts their rehabilitation and
      improves their health.

      Secondary hypotheses are:

        -  The ABLE Exoskeleton device will improve the kinematics and spatiotemporal parameters of
           gait (more closely resemble the gait pattern of a healthy individual), relative to
           KAFO-type orthoses.

        -  The ABLE Exoskeleton device will have a more positive impact on the mobility and
           psychosocial health of participants with SCI in the study, with respect to KAFO-type
           orthoses.

        -  The ABLE Exoskeleton device is a safe device to use in a hospital setting as an
           assistive device during gait rehabilitation in SCI patients.
    

Intervention name(s): ABLE Exoskeleton; KAFO Orthosis
Intervention type(s): Device; Device
Intervention description(s): Participants will use the ABLE Exoskeleton to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.; Participants will use a pair of KAFO-type passive orthosis to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete 10 gait training sessions during a 5-week period with one of the two devices (ABLE Exoskeleton or KAFO orthoses) followed by a post-training assessment. After the training program with the first device, participants will have 2 weeks resting time, after which they will repeat the process with the other device. The initial device assignment (ABLE Exoskeleton or KAFO) is performed randomly.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Exoskeleton; KAFO; Gait; Rehabilitation; Lower-limb; Gait Kinematics; Robotics; Energy Efficiency; Oxygen Consumption; Gas exchange; Neurorehabilitation; Paraplegia; Walking; Passive orthoses; Assistive technology; Usability; Randomized crossover