Role of Virtual Reality in MS Rehabilitation

Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis Relapse
• Intervention / Treatment: Device: Lokomat

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3)
• Montreal Cognitive Assessment score ≥24
• Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation.

Exclusion Criteria:

• MS relapse during the three months prior to recruitment
• Not well defined pharmacological therapy; 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 130kg body weight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: column heading in tables.; The group 1 (G1, n=20) underwent Lokomat-Nanos training. Each patient underwent 40 1h-training sessions (for 3 times a week). Both the study groups were treated by Lokomat (Hocoma Inc., Zurich, Switzerland), which includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . The overall duration of Lokomat therapy, including the time to get on and off, was 60min, while the robotic gait training lasted around 40min.	Device: Lokomat; 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.
Active Comparator: row and column in table; The group 2 (G2, n=20) underwent Lokomat-Pro training, with the same G1 sessions. The Pro device offers instead 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.	Device: Lokomat; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	BBS is a clinical scale to evaluate balance	Up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Orientation to Problem Experienced	The test is aimed at evaluating how a person deals with a specific problem, with two main coping strategies, i.e. adaptation and avoidance.	Up to 14 weeks

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Virtual reality; Lokomat;; robotic rehabilitation.; Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 24/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are planning this.