Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
Condition: Neuromuscular Diseases; Cerebral Palsy; SMA II
MeSH terms: Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The purpose of this multicentric study is to assess the rehabilitative effect derived from
      the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy
      and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as
      a consequence of their disease, as well as the assessment of other physical, functional and
      quality of life parameters of interest. For this purpose, the exoskeleton will be used as a
      rehabilitation and walking assistance tool.

      Before starting the study programme and if deemed necessary, a preliminary phase consisting
      of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton
      for the first time and it will be considered whether any improvements to the different parts
      of the device or the software are necessary to increase the ergonomics and comfort of the
      patient.
    

Detailed description: 
      The objectives of the study are:

        -  Objective 1: To assess the safety and physical and physiological tolerance of the child
           to the activity performed with the exoskeleton in the rehabilitation sessions.

        -  Objective 2:

        -  To assess the safety of a progressive treatment algorithm to achieve the safe
           progression of patients throughout the therapy

        -  To assess whether an improvement is achieved in parameters related to the physical
           rehabilitation of the patient using the exoskeleton, in respiratory capacity,
           self-perceived quality of life (physical and emotional well-being and self-esteem) as
           well as to assess the effectiveness of a psychological intervention to provide support
           in coping with the situation of using the device for the first time in those children
           who have not used it before.

      The time period of the study will be as long as necessary to reach the desired number of
      participants, in this case 10 children (N=10). The participants will be patients affected by
      neuromuscular diseases or cerebral palsy and will be selected on the basis of the following
      inclusion/exclusion criteria:

      Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait
      disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.

      Exclussion criteria: not fulfil the usage criteria of the device.
    

Intervention name(s): ATLAS 2030
Intervention type(s): Device
Intervention description(s): The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.
Other intervention name(s): Robot Asissted Gait Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gait Exoskeleton; Robotics; Children; ATLAS 2030; Neuromuscular disease; Cerebral Palsy; Rehabilitation