Locomotor Training With Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this observational, non-controlled, non-profit study is to describe the responses
      to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete
      motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient
      intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the
      device are also assessed and described.
    

Detailed description: 
      The locomotor training, defined as any "therapeutic program aimed at the recovery of walking
      through intense practice of the task of walking", is a very important part of the treatment
      plan for patients with locomotor dysfunction of the lower extremities and is aimed at
      retraining the nervous system, facilitating the recovery of muscle strength, improving
      balance and voluntary motor coordination. In fact, the majority of gait rehabilitation
      strategies is based on the concept of plasticity of the Central Nervous System and of
      "Central Pattern Generator": this plasticity is supposed to be facilitated by early,
      intensive and specific therapies, able to enhance the natural recovery processes.

      The final goal is to help patients regain the highest level of personal autonomy which
      consequently translates also in a better overall quality of life.

      The anthropomorphic robotic exoskeleton EKSO (Ekso Bionics, USA) is designed to assist in
      upright, weight bearing over ground gait training of people with weakness or paralysis of the
      lower limbs, due to a disorder, a disease or a neurologic injury. The training with EKSO is
      possible even in the presence of minimal forearm strength in order to resting to an upfront
      mobile walker. The device is available on the market for some years and it has recently been
      introduced in the clinical practice of some Italian rehabilitative centers. Montecatone
      Rehabilitation Institute acquired the most recent "GT" version of EKSO that enables variable,
      adaptive assistance.

      This observational, longitudinal research study has a descriptive/exploratory intent. It aims
      at describing the responses to rehabilitative training with the robotic exoskeleton EKSO-GT
      in a cohort of incomplete motor Spinal Cord Injury patients (AIS C or D), as a rehabilitative
      tool in a setting of intensive inpatient rehabilitation (3rd level hospital). Safety and
      tolerability are also assessed and described.

      This kind of study is justified by the fact that although the global network of professional
      users agree on the potential of such "young" technology on rehabilitation outcomes, few are
      the clinical data published in the scientific literature in relation to its use. It is
      believed that the results obtained from this study will be useful for the future definition
      of better protocols of use of the exoskeleton, more specific for the different types of SCI
      people.

      Primary objective: to describe the responses to the robotic over ground gait training with
      EKSO-GT in an inpatient rehabilitative hospital setting, in people with incomplete motor SCI
      (AIS C or D). This objective is achieved by means of the administration of walking tests and
      the assessment of both lower limbs motor function and kinetic and endurance characteristics
      of walking.

      Secondary objectives, description in the same patients' population:

        -  Safety and tolerability of locomotor training with the EKSO-GT;

        -  Level of strength and muscle trophism of the patient subjected to the robotic training;

        -  Any reductions in pain and/or spasticity due to SCI during and after the locomotor
           training with the EKSO-GT;

        -  Quality of life and mood status of patients;

        -  Level of patient satisfaction in relation to the gait training with the EKSO-GT;

        -  Maintenance of any acquired benefits (follow-up 45 days after the conclusion of the
           training with the EKSO-GT), with respect to most outcomes taken into account.

      All functional assessments are carried out when the patient does not wear the exoskeleton;
      however, functional gait specific test (10-meter walk test and 6-minutes walk test) are
      performed when the exoskeleton is worn and when it is not worn only by those patients able to
      accomplish those gait specific tests in such a way.

      For gait specific tests the first evaluation with the exoskeleton worn is programmed to the
      third robotic rehabilitative session, as the first sessions are necessary for set-up
      purposes.

      Data on the safety and tolerability of the EKSO-GT training are recorded at the beginning and
      at the end of each session, however a synthesis of safety outcomes will be carried out at
      predefine time frames.

      The training with the EKSO-GT is carried out in addition to the "conventional" locomotor
      training and in the presence of specifically trained physiotherapists, always under medical
      supervision.

      Patients undergo 12 or 18 rehabilitative EKSO sessions, 2-3 times per week, of max 1 hr each.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Incomplete motor SCI patients in a setting of inpatient intensive rehabilitation (3rd level
        hospital)
      
Keywords: incomplete motor SCI; robotic gait training; exoskeleton; rehabilitation tool; EKSO-GT