LEAP a New Overground Body Weight Support Robot: Usability Trial
Condition: Spinal Cord Injuries; Cerebral Palsy; Parkinson Disease; Multiple Sclerosis; Stroke; People With Impaired Lower Extremity Function
MeSH terms: Parkinson Disease; Multiple Sclerosis; Spinal Cord Injuries; Cerebral Palsy; Body Weight
Study type: Interventional

Summary: 
      People with central nervous system disorders such as spinal cord injury, stroke, cerebral
      palsy, Parkinson's disease, multiple sclerosis, etc… often have impaired lower extremity
      function that limits activities of daily life and independence. Different body-weight support
      systems have been developed to facilitate the rehabilitation process by compensating for the
      user's residual abilities. However, studies on weight-supported gait training on a treadmill
      have failed to show superiority over conventional rehabilitation programs for spinal cord
      injury and stroke. A recent study by the group around Grégoire Courtine showed that
      body-weight support systems that provide assistance only in the vertical direction disrupt
      the production of gait and balance, suggesting that current practices may even be detrimental
      for relearning to walk. For the past year, the Clinique Romande de Réadaptation (CRR) worked
      together with the G-Lab at EPFL and G-Therapeutics on a new robot platform specifically
      developed to provide adjustable trunk support along four independent degrees of freedom
      (LEAP). The investigators were able to draw on their long-term experience, which consists of
      different body weight support training systems for stroke and spinal cord injury. This
      knowledge, combined with the input of our therapists and physicians and the specific
      requirements for people with neurological/musculoskeletal disorders, has resulted in a design
      that can provide adjustable bodyweight support during over-ground locomotion, treadmill,
      stairs training, standing up and sitting down and for support during the training of
      activities of daily living.

      The scope of this study is to examine how well the robot can be used for rehabilitation
      therapy in everyday clinical practice. This includes, among other things, technical aspects
      such as the handling of the hardware, the adaptability of the robot to the patient, and the
      safety during operation (such as the fall prevention). Various patient-specific aspects will
      also be evaluated e.g. comfort, positioning, or motivation of the patient. This study also
      aims to evaluate the software with the various support modes, operating options, and the user
      interface of the LEAP.
    


Intervention name(s): Therapist LEAP session feedback; Participant LEAP session feedback; LEAP risk control validation
Intervention type(s): Device; Device; Device
Intervention description(s): A standard therapy session is being performed with a participant with the LEAP body-weight support robot. Subsequently, the therapist is answering a questionnaire to assess the clinical applicability of the robot. An observer will assess with a questionnaire whether use errors occurred during the session.; A standard therapy session is being performed with a participant inside the LEAP body-weight support robot. Subsequently, the participant is answering a questionnaire to assess the comfort of the robot.; The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other