Stroke Rehabilitation With Exoskeleton-assisted Gait.
Condition: Severe Stroke; Acute Stroke; Chronic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mild Stroke
MeSH terms: Stroke; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Cardiovascular Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted
      practice has shown positive outcomes. However, literature lacks of clinical studies on
      exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™,
      EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk,
      involving them directly in steps trigger through body weight balance. The main aim of this
      study is to assess the clinical and neuromuscular effects of exoskeleton-based gait
      rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar
      characteristics who will conduct a traditional over-ground gait training.

      In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the
      Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12
      one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait
      rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity
      Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter
      walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and
      Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the
      training period. The primary outcome is the distance performed during the 6mwt. A follow up
      study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.
    

Detailed description: 
      *Procedures During Screening Process:

      This multicentric study will involve recruitment of individuals who have experienced a middle
      to severe stroke as well as patients with similar neurological weakness from the inpatient
      setting, outpatient clinics, as well as day rehabilitation sites through all the health
      institutes participating to this study project. Members of the research teams will perform
      the initial screening of potential subjects. These clinicians will determine study
      eligibility based on the inclusion and exclusion criteria provided by Ekso Bionics in
      accordance with the medical recommendations of Prof. Marco Franceschini.

      Potential subjects will be asked questions regarding their medical history and current level
      of function. If the subject meets the criteria, researchers will then provide the subject
      with a consent form. The researchers will discuss the objectives, the study protocol, and the
      risks and benefits to each subject. The subjects will be given time to review the form and
      ask any questions about it.

      Once each subject has provided informed consent, he or she will undergo a screening process
      to assess the joint range of motion, and any spasticity present (via Modified Ashworth
      Scale). These measures will be used to determine subject qualification based on inclusion and
      exclusion criteria. Vital signs (including heart rate, blood pressure and oxygen saturation)
      will be assessed at baseline, after each session, and during sessions as needed based on
      subject's signs and symptoms. Oxygen saturation and heart rate will be monitored using a
      pulse oximeter. Blood pressure will be assessed with a manual blood pressure cuff and
      stethoscope.

      Participants will be screened at the first therapy session (T1) and at the last one (T2).
      Follow-up assessments will also take place at 1 month (T3) and 3 months (T4) after the end of
      treatment.

      *Procedures During Treatment: The enrolled stroke patients will be randomly assigned to the
      Experimental Group (EG) or to the Control Group (CG). All patients will conduct gait therapy
      for at least 12 (subacute patients) or 18 (chronic patients) one-hour-sessions (about 3
      times/ week).

      Experimental Group (EG): Exoskeleton-Assisted Over ground Gait Training Sessions will begin
      with donning the Ekso device to ensure a proper fit. A physical therapist will check the
      subject for proper alignment of joints with the device and check for areas of increased
      pressure between the device and body. If necessary, additional padding will be added to
      ensure safety and comfort or the device configuration will be modified. During the initial
      sessions, skin checks will be occur more frequently at the end of each session to customize
      well the padding. Moreover, the identification of the best exoskeleton settings for each
      patient will be conducted for planning a customized and tailored robotic treatment.

      During the treatment, the subject will be trained in interfacing with the exoskeleton Ekso
      with optimal postural alignment, and weight shifting strategies. No strength is required from
      the patient; only proper balance and weight shifts are required to achieve walking since
      steps are triggered by the user's lateral weight shift. Enrolled patients will undergo 60
      minute long sessions of gait training using the powered wearable exoskeleton. Patients will
      conduct robotic training in conjunction with conventional physiotherapy training.

      Control Group (CG): Traditional Over ground Gait Training The control group will perform 60
      minute long sessions of Traditional Over ground Gait Training with a senior physiotherapist.
      In the starting phase, the gait task can be facilitated by the physiotherapist or by using
      aids, such as walkers, tripods etc.

      Traditional Over ground Gait Training includes:

        -  Sit-to-Stand tasks

        -  Exercises for upright position control (right/left load shift): these tasks will allow
           to include people who are unable to walk in the CG.

        -  In case of patients able to walk or once this turns possible, they will be trained to
           re-learn a correct pattern of gait while walking over the ground.

      CG patients will not use any other robots or treadmill for gait training.
    

Intervention name(s): Exoskeleton-Assisted Gait Training
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Robot; Hemiparesis; Gait Training; Rehabilitation; Exoskeleton; Functional Recovery