Role of Virtual Reality in MS Rehabilitation

NCT02834533 | Completed DMC

• 1 other identifier: 24/2014
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Sclerosis Relapse

Keywords

Lokomat;; robotic rehabilitation.; Multiple Sclerosis;; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  BBS is a clinical scale to evaluate balance

  Up to 14 weeks

Secondary Outcomes (1)

• Coping Orientation to Problem Experienced

  Up to 14 weeks

Study Arms (2)

column heading in tables.

ACTIVE COMPARATOR

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

row and column in table

ACTIVE COMPARATOR

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

Interventions

Lokomat DEVICE

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.

column heading in tables.; row and column in table

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 15, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 18, 2016

Record last verified: 2016-07