Overview
Clinical trial involving a medical device, not intended for CE marking, randomized, blinded to evaluate the efficacy of preparatory treatment with Intensive Visual Simulation 4 (IVS) prior to exoskeleton-assisted (EKSO) step training in achieving independent ambulation in hemiparetic patients with impaired proprioceptive sensation. Patients will be randomized into two groups: one group in which patients will undergo IVS treatment before physiotherapy and robotic step training with an exoskeleton; and one group in which patients will undergo only physiotherapy and robotic step training with an exoskeleton.
Description
Enrolled patients will be randomized to one of the two rehabilitation treatment arms included in the trial.
- Arm A: Rehabilitation treatment with IVS before physiotherapy-based and robotic gait training using an exoskeleton.
- Arm B: Rehabilitation treatment with physiotherapy-based and robotic step training using an exoskeleton.
Training will last:
- 15 minutes of IVS (only for Arm A)
- 30 minutes of EKSO training (which in Arm A will be performed after IVS treatment)
- 45 minutes of non-robotic motor therapy following robotic treatment.
Each rehabilitation session will last a maximum of approximately 1.5 hours and will be repeated 5 days a week for 3 weeks.
Clinical evaluations will be conducted by a physician who is unaware of the rehabilitation treatment the patient has undergone (the patient will be appropriately informed of the need not to disclose the type of rehabilitation received to the evaluating physician).
Eligibility
Inclusion Criteria:
- Male and female patients aged 18 to 80 years (both ends included).
- Diagnosis of hemiparesis/plegia with proprioceptive sensory deficit due to a cerebrovascular event within the last 6 months
- Orientation in the 3 domains (space, time, and person)
- Cooperation
- Clinical stability
- Trunk control while standing
- Signature of the Informed Consent Form for participation in the study and for the processing of personal data
Exclusion Criteria:
- Patients aged \< 18 years and \> 80 years
- Patients who are disoriented in at least one of the three domains (space, time, and person)
- Non-cooperative patients
- Patients with global aphasia
- Patients with severe ideomotor apraxia
- Patients with cognitive or mental disorders
- Patients not eligible for EKSO:
- Severe comorbid conditions: infections, circulatory, cardiac, or pulmonary diseases, pressure ulcers.
- Severe spasticity (level 4 on the modified Ashworth scale).
- Spinal instability or unhealed fractures of the limbs or pelvis.
- Heterotopic ossification.
- Psychiatric or cognitive conditions that may interfere with the proper use of the device.
- Pregnant women.
- Reduced tolerance for standing due to orthostatic hypotension.
- Range of motion (ROM) limitations that would prevent the patient from achieving a normal bilateral gait pattern or performing normal transitions from a seated to a standing position and vice versa: Bilateral hip flexion less than 110°, knee flexion contracture greater than 12°, or inability to achieve neutral dorsiflexion of 0° with knee flexion up to 12°.
- Leg length discrepancy greater than 1.27 cm for the upper leg and 1.9 cm for the lower leg.
- Unresolved deep vein thrombosis.
- Uncontrolled autonomic dysreflexia.
- Lower limb prostheses.
