Role of Virtual Reality in MS Rehabilitation
Condition: Multiple Sclerosis Relapse
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait
      training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).

      Method: A Randomized, double-blind, controlled clinical trial was carried out in forty
      patients with relapsing remitting MS. All patients were randomized into two groups. One group
      practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the
      groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded
      neurologist and psychologist administered clinical and neuropsychological scales. All the
      clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative
      program.
    

Detailed description: 
      METHODS The present study is a single-blind randomized trial, conducted according to the
      Declaration of Helsinki, the guidelines for Good Clinical Practice, and the (CONSORT)
      Statement guidelines. The study protocol was approved by our Institutional Review Board and
      Ethics Committee (project number: 24/2013).

      One hundred and fifty consecutive outpatients with relapsing-remitting multiple sclerosis and
      gait and/or balance disturbance, attending the Laboratory of Robotic Neurorehabilitation of
      the IRCCS Neurolesi Bonino-Pulejo (Messina, Italy) from January 2015 to January 2016, were
      invited to participate in the study, and were screened for study eligibility.

      Inclusion/exclusion criteria Inclusion criteria were: age 30-65 years; severe walking
      disability with Expanded Disability Status Score between 3.5 and 6.0 (Piramidal subitem ≥3);
      Montreal Cognitive Assessment score ≥24; absence of concomitant neurological or orthopedic
      conditions that may interfere with ambulation; stable pharmacological therapy for at least 6
      months. Exclusion criteria were: multiple sclerosis relapse during the three months prior to
      recruitment; presence of paroxysmal vertigo; lower limb botulinum toxin injections within the
      previous 12 weeks; cardiorespiratory instability; high-risk of spontaneous fracture;
      lower-limb skin lesions and phlebitis/thrombosis; more than 130 kg body weight.

      Randomization Forty out of 150 outpatients with relapsing remitting multiple sclerosis form,
      according to Polman criteria14 selected between January 2015-2016, were enrolled and
      randomized and allocated into either Group1 (G1 i.e. Lokomat-Nanos) or Group2 (G2 i.e.
      Lokomat-Pro), as shown in fig 1. The subjects were randomly assigned to one of two treatment
      groups, using a simple randomization scheme generated by a software (www.randomization.com).
      Individual, sequentially numbered index cards with the random assignments were prepared. The
      index cards were folded and placed in sealed opaque envelopes. A physician member of the
      research team, who was blinded to the baseline examination findings, opened the envelopes to
      attribute the interventions according to the group assignments.
    

Intervention name(s): Lokomat
Intervention type(s): Device
Intervention description(s): Lokomat (Hocoma Inc., Zurich, Switzerland)includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . As compared to Lokomat-Nanos, the Pro device offers a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Lokomat;; robotic rehabilitation.; Multiple Sclerosis;; Virtual reality