RecruitingRecruiting
Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients
NCT06735053 · European University of Madrid
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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 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.
Study design
Enrollment target: 26 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-02
Estimated completion: 2025-07
Last updated: 2025-02-21
Interventions
Other: Virtual Reality groupOther: Placebo virtual reality group
Primary outcomes
- • Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS) (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.)
Sponsor
European University of Madrid · other
Contacts & investigators
ContactMarina Castel-Sánchez, PhD · contact · marina.castel@universidadeuropea.es · 0034 + 679448994
ContactAlberto Bermejo-Franco, PhD · contact · alberto.bermejo@universidadeuropea.es · 0034 + 656932144
All locations (2)
Asociación Mostoleña de Esclerosis Múltiple (AMDEM)Recruiting
Móstoles, Madrid, Spain
Fundación Esclerosis Multiple Madrid (FEMM)Recruiting
Madrid, Spain