Experimental Study on the Impact of a Virtual Reality-Based Physiotherapy Program as a Complement to a Conventional Physiotherapy Program in Patients With Moderate to Severe Multiple Sclerosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Fundación Esclerosis Multiple Madrid (FEMM)
RECRUITING
Madrid
Asociación Mostoleña de Esclerosis Múltiple (AMDEM)
RECRUITING
Móstoles
Contact Information
Primary
Marina Castel-Sánchez, PhD
marina.castel@universidadeuropea.es
0034 + 679448994
Backup
Alberto Bermejo-Franco, PhD
alberto.bermejo@universidadeuropea.es
0034 + 656932144
Time Frame
Start Date: 2025-02
Estimated Completion Date: 2025-07
Participants
Target number of participants: 26
Treatments
Experimental: Virtual Reality group
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.
Placebo_comparator: Placebo Virtual reality group
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.
Related Therapeutic Areas
Sponsors
Leads: European University of Madrid

This content was sourced from clinicaltrials.gov