PURO - PUlmonary Rehabilitation With O-RAGT Platform
Condition: Multiple Sclerosis; Spinal Cord Injury; Stroke; Traumatic Brain Damage
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The goal of this interventional study is to assess differences in the metabolic consumption,
      the cardiorespiratory effort, the cardiac autonomic adaptation, and fatigability during ADL,
      such as standing from a chair and walking while wearing an electrically powered exoskeleton
      in different modes of supports in subjects with neurological diseases with moderate to severe
      walking impairments.
    

Detailed description: 
      In people with severe gait impairments due to neurological diseases walk recovery is one
      primary goal, since achieving independent ambulation is a major contributing factor to their
      quality of life. Beyond walking, other very common Activities of Daily Living (ADL), such as
      postural transitions (which requires an integrity of the autonomic control mechanisms of
      blood pressure) and stair climbing (which requires the necessary strength in the lower limbs
      to lift one's own body weight) should be guaranteed by any rehabilitative intervention.
      Although physiotherapy treatments have proven effectiveness in improving gait and balance,
      conventional overground walking training may be very difficult or even impossible for
      patients with moderate to severe gait problems and limited cardiovascular capacity due to a
      too high energy demand (exercise intensity) (Calabrò 2022).

      Wearable powered exoskeletons could be used to provide overground robotic assisted gait
      training (RAGT). Indeed, RAGT has shown clinically significant improvements in gait and
      balance outcomes and could be considered a valid approach to enhance gait function in people
      with severe gait impairments due to neurological diseases(Bowman 2021).

      Little is known about the impact of robotic training on cardiovascular parameters and the
      metabolic / energy cost of walking with a wearable powered exoskeleton compared to unassisted
      overground walking in population with neurological diseases. It is possible that exoskeletons
      allow walking while keeping cardiorespiratory effort under control with a lower metabolic
      cost.

      Moreover, people with severe gait impairments can suffer from disturbed cardiac autonomic
      control during exercise which affects exercise tolerance and balance during orthostatic
      challenges, such as the sit-to-stand maneuver. Indeed, to recommend RAGT in people with
      neurological diseases with moderate to severe gait impairments, the impact of the cardiac
      autonomic tone on sit-to-standing and walking with an exoskeleton should be investigated.

      The use of an assisted as needed exoskeleton in clinical practice with population with
      moderate-severe neurological disabilities could increase their locomotor function by reducing
      the impact on metabolic consumption and cardiorespiratory effort compared to conventional
      overground walking training without an exoskeleton. Moreover, cardiovascular autonomic
      dysfunction (CAD), if any, should not be worsened by walking with an exoskeleton compared to
      conventional overground walking training, and should not constitute an impediment in the
      adaptation of the cardiovascular adaptation (especially of blood pressure) to the postural
      transitions.

      The goal of this interventional study is to assess differences in the metabolic consumption,
      the cardiorespiratory effort, the cardiac autonomic adaptation, and fatigability during ADL,
      such as standing from a chair and walking while wearing an electrically powered exoskeleton
      in different modes of supports in subjects with neurological diseases with moderate to severe
      walking impairments.
    

Intervention name(s): UANGO suite exoskeleton
Intervention type(s): Device
Intervention description(s): Each subject will perform 3 experimental conditions (Condition 1: Walking without exoskeleton; Condition 2: Walking with exoskeleton; Condition 3: Walking with exoskeleton and walker).
Each condition includes 5 triasl (Trial 1 - Sitting: 5 minutes, sitting at rest in comfortable position; Trial 2 - Standing: 5 minutes, with assistance; Trial 3 - Comfortable speed Walking (100% assisted): 4 min during back-and-forth locomotion on a 20-m length linear flat path; Trial 4 - Comfortable speed Walking (75% assistance): 4 min during back-and-forth locomotion on a 20-m length linear flat path, Trial 4 is not available in condition 1; Trial 5 - 1 minute Sit to stand test). Nasa TLX and RPE will be requested at the end of each trial. Usability questionnaires will be fullfilled at the end of condition 2 and condition 3.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other