Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients

Official title

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

Overview

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.

Interventions

• Other 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
• 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 b

Primary outcome measures

• Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS) [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]

Secondary outcome measures (7)

• Change in Physical and psicological impact of Multiple Sclerosis on patients'life measured with Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in manual dexterity and fine motor skills [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in gross motor manual dexterity [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in functional independence to perform activities of daily living [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in the ability to perform instrumental activities of daily living [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in cognitive function [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]
• Change in physical, mental and social healths aspects related to quality of life [Time frame: The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Asociación Mostoleña de Esclerosis Múltiple (AMDEM) — Móstoles
• Fundación Esclerosis Multiple Madrid (FEMM) — Madrid

Identifiers

NCT: NCT06735053 · 24/765-EC_P

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗