Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients

European University

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Virtual Reality group; Other: Placebo virtual reality group

Study type: Interventional

Funder types: Other

Identifiers

NCT06735053

24/765-EC_P

Details and patient eligibility

About

The goal of this clinical trial is to learn if virtual reality combined with conventional physiotherapy intervention works to treat moderate to severe multiple sclerosis persons. The main questions it aims to answer are:

• Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in motor aspects of patients with multiple sclerosis?
• Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in cognitive aspects of patients with multiple sclerosis

Researchers will compare a virtual reality-based program along with conventional physiotherapy with a placebo virtual reality to see if virtual reality improve motor and cognitive aspects of multiple sclerosis.

Participants will:

• Visit the clinic twice a week for 10 weeks to receive a 1-hour session of virtual reality and conventional physiotherapy.
• Be assessed using various scales and questionnaires at three different times: at the start of the study, at the end of the treatment, and 4 weeks after the study ends.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years.
• All patients with Multiple Sclerosis are included according to the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) (ANNEX II) with a score greater than or equal to 6.5 (Need of two types of support to walk -two canes, walker...- about 20 meters without resting).
• Stable medical treatment for at least six months prior to intervention.
• Absence of cognitive impairment, with ability to understand instructions and to obtain a score equal to or greater than 24 on the Minimental Test.

Exclusion criteria

• Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
• Diagnosis of any cardiovascular, respiratory or metabolic disease, or other conditions that may interfere with this study.
• To have suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, nor during the therapeutic intervention process.
• To have received a course of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
• Visual disturbances not corrected by ocular devices.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Virtual Reality group

Experimental group

Description:

The intervention group will carry out a physiotherapy program using virtual reality and conventional treatment for 10 weeks. They will receive 2 weekly treatment sessions of 60 minutes distributed in 45 minutes of physiotherapy using the virtual reality based device (Dynamics VR) following a therapeutic protocol where patients will have exercise sessions based on the theory of motor learning with upper limb and trunk work including fine motor and gross motor exercises, trunk control and postural control exercises, increasing the level of demand or difficulty of the exercises as the weeks go by. Additionally, they will receive a complement of 15 minutes of treatment with conventional physiotherapy directed to the specific needs of each patient.

Treatment:

Other: Virtual Reality group

Placebo Virtual reality group

Placebo Comparator group

Description:

The control group will carry out a conventional physiotherapy program for 10 weeks in which they will receive 2 weekly treatment sessions of 60 minutes distributed in 45 minutes of physiotherapy and 15 minutes of treatment with online virtual reality placebo.

Treatment:

Other: Placebo virtual reality group