Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients

NCT ID: NCT06735053

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality group

Intervention Type: OTHER

Virtual reality group will perform online reality-based device following a therapeutic protocol supervised by a physiotherapist in which the level of demand will be adjusted to the patient's evolution. This programme provides a gamified and challenging online environment to enhance motor learning and induce sensorimotor adaptations. Additionally, they will receive conventional physiotherapy approach, oriented to the specific objectives of each patient, aiming to normalize tone, activate weakened muscles, facilitate movement, recover sensitivity, and compensate for functional deficits. Additionally, global kinesitherapy, motor coordination exercises, pedalier, vibration therapy (vibrosphere®), and analgesic electrotherapy will be performed if necessary.

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.

Group Type: PLACEBO_COMPARATOR

Placebo virtual reality group

Intervention Type: OTHER

The control group will undergo a conventional physiotherapy program based on the normalization of tone, activation of weakened muscles and facilitation of normal movement, recovery of alterations in sensitivity, and compensation of lost functional deficits. In addition, global kinesitherapy exercises will be performed on a stretcher, motor coordination exercises, pedalier, vibration therapy (vibrosphere ®) and analgesic electrotherapy if necessary. Finally, in order to minimize the differences between the control and intervention groups, the participants of the control group will watch a 15-minute generic 2D video freely accessible on the Youtube platform from the VR glasses, without specific software.

Interventions

Virtual Reality group

Virtual reality group will perform online reality-based device following a therapeutic protocol supervised by a physiotherapist in which the level of demand will be adjusted to the patient's evolution. This programme provides a gamified and challenging online environment to enhance motor learning and induce sensorimotor adaptations. Additionally, they will receive conventional physiotherapy approach, oriented to the specific objectives of each patient, aiming to normalize tone, activate weakened muscles, facilitate movement, recover sensitivity, and compensate for functional deficits. Additionally, global kinesitherapy, motor coordination exercises, pedalier, vibration therapy (vibrosphere®), and analgesic electrotherapy will be performed if necessary.

Intervention Type: OTHER

Placebo virtual reality group

The control group will undergo a conventional physiotherapy program based on the normalization of tone, activation of weakened muscles and facilitation of normal movement, recovery of alterations in sensitivity, and compensation of lost functional deficits. In addition, global kinesitherapy exercises will be performed on a stretcher, motor coordination exercises, pedalier, vibration therapy (vibrosphere ®) and analgesic electrotherapy if necessary. Finally, in order to minimize the differences between the control and intervention groups, the participants of the control group will watch a 15-minute generic 2D video freely accessible on the Youtube platform from the VR glasses, without specific software.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University of Madrid

OTHER

Sponsor Role: lead

Responsible Party

Marina Castel Sánchez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asociación Mostoleña de Esclerosis Múltiple (AMDEM)

Móstoles, Madrid, Spain

Site Status: RECRUITING

Fundación Esclerosis Multiple Madrid (FEMM)

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marina Castel-Sánchez, PhD

Role: CONTACT

marina.castel@universidadeuropea.es

0034 + 679448994

Alberto Bermejo-Franco, PhD

Role: CONTACT

alberto.bermejo@universidadeuropea.es

0034 + 656932144

Facility Contacts

Marina Castel-Sánchez, PhD

Role: primary

marina.castel@universidadeuropea.es

0034 + 679448994

Marina Castel-Sánchez, PhD

Role: primary

marina.castel@universidadeuropea.es

0034 + 679448994

Other Identifiers

24/765-EC_P

Identifier Type: -

Identifier Source: org_study_id