A stroke is a vascular condition that can suddenly cause the loss of neurological functions.
      The disability derived from a stroke can imply reduced communication and limited activities
      of daily living in the long term.

      Thus, specifically walking rehabilitation is crucial in order to restore the lower limbs'
      function and to re-establish the social participation of patients.

      Robotics has been demonstrated in being a suitable and effective tool in order to assist and
      treat post-stroke patients, thanks to its capability to deliver intensive and task-oriented
      training. Specifically, the exosuits, are a sub-group of robotics devices designed in lighter
      materials that assist the patients by actively moving the hip, knee or ankle.

      Given this framework, the aim of this work is to conduct a pilot study on the usability and
      perceived effectiveness of a lower-limb exosuit, the Myosuit device, on post-stroke patients.
      The secondary aims of the study concern the evaluation of the functional performances of the
      patients both with and without the device and before and after the treatment.

Myosuit Chronic Stroke Protocol

Stroke

Ischemic Stroke

Haemorrhagic Stroke

A stroke, either ischemic or haemorrhagic, is a vascular condition that can suddenly cause
      the loss of neurological functions [1]. The disability derived from a stroke can imply
      reduced communication and limited activities of daily living in the long term. Specifically,
      reduced mobility and equilibrium, walking asymmetry and spasticity of the impaired limb are
      the principal factors related to long-term limited physical activity and moderate dependency
      of the patient on the caregiver [2,3]. A walking deficit can have severe consequences on the
      energetic cost and the risk of falling, as well as on the participation and personal identity
      of the person [4].

      Moreover, another psychological area that can be affected is self-efficacy, defined as the
      individual capabilities to take actions for obtaining results. Hence, for a person affected
      by stroke, self-efficacy is crucial and connected to his/her adaptation to the new condition
      [5].

      For these reasons, walking rehabilitation is essential to recover lower limbs' function,
      restore self-efficacy and re-establish the social participation of patients [6].

      Robotics has been demonstrated in being a suitable and effective tool in order to assist and
      treat post-stroke patients [7], thanks to its capability to deliver intensive and
      task-oriented training. One of the most common modalities to classify robotics devices is
      according to their structure, and the modality to interface with the patients. In these
      regards, we can distinguish between exoskeletons and end-effector robots, given their
      characteristics to wear the patient and guide him/her through the distal handle of the
      mechanical chain, respectively. Moreover, among the exoskeletons, the exosuits are a
      sub-group of robotics devices designed in lighter materials and that assist the patients by
      actively moving the hip, knee or ankle.

      The lightweight of exosuits makes them suitable both for ecological and therapy-related
      settings, as well as assistance applications. It is also worth noticing that the absence of a
      rigid structure requires the patients to have an active component in the walking activity.
      Previous studies highlighted how these devices can have a supportive capacity during the
      propulsion phases of gait, assisting the patients throughout the walk [8].

      The Myosuit device is a wearable exosuit capable to provide assistance during the walk, sit
      to stand transition and stair climb [9]. Its assistance is provided with an exo-tendon
      mechanism. More in detail, online analysis of inertial signals allows to segment the gait
      phases and to assist at the extension of the knee and hip [9].

      Many previous studies show promising results in the deambulation of spinal cord injuries or
      patients with lower-limb disorders [9,10]. These results were evaluated both in terms of
      kinematics and the safety of the patients. However, the studies conducted to highlight the
      urgency for the validation of the device in bigger and different cohorts [9,10].

      Given this framework, the aim of this work is to conduct a pilot study on the effects of a
      lower-limb exosuit, the Myosuit device, on post-stroke patients. The effects of the device
      will be analysed in terms of usability of the device, self-efficacy, and functional
      parameters of gait.

Lower-limb robotic intervention

Valutazione Degli Effetti di un Dispositivo Indossabile Per Arto Inferiore (Myosuit) Sulla accettabilità e Parametri Funzionali di Pazienti Cronici Post-ictus: Studio Pilota.

System Usability Scale (SUS) Range: 0-100, with 100 corresponding to the highest degree of usability

Stroke Self-Efficacy Questionnaire (SSEQ-10) Range: 0-39; with 39 corresponding to the maximum confidence of the patient in self-efficacy

Short Physical Performance Battery (SPPB) Range: 0-12; with 12 corresponding to the best perfromance on balance, walking, and sit-to-stand tasks

Distance walked during the Two Minutes Walking Test (2minWT), in meters
Range: Not available; higher distances represent better performances on the walking task

Time needed to execute the 10 Meters Walk Test (10mWT), in seconds
Range: Not available; higher durations represent worst performances on the walking task

Time needed to execute the Stair Climb Test (SCT), in seconds
Range: Not available; higher durations represent worst performances on the stair climb task

Spatio-temporal kinematic parameters extracted from the Optogait system, such as:
step length (meters)
stride length (meters)
stride time (seconds)
step time (seconds)
swing time (seconds)
cadence (steps/minute)
velocity (meters/seconds)

The intervention administered in this arm is a lower limb robotic intervention using the device Myosuit. The intervention includes:
An enrollment (session1), in which a clinical and psychological evaluation is performed for the assessment of the inclusion criteria
A baseline evaluation (session2), in which a functional evaluation is performed both with and without the device
Training sessions (sessions 3-9), these are the actual training sessions in which walking, sit to stand, balance and stairs climbing tasks are performed with the device on
Final evaluation (session 10), in which a final functional, clinical, and psychological assessment is performed
The sessions are performed 3 times per week, with a duration of 45 minutes, with the expection of the assessement ones, session 1, 2 and 10, that have a duration of 1h, 2h and 3h, respectively.

Myosuit Chronic Stroke Protocol

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status