Clinical trial NCT06735053: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
virtual reality
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS)
timeFrame: 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 outcomes:
measure: Change in Physical and psicological impact of Multiple Sclerosis on patients'life measured with Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 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.
measure: Change in manual dexterity and fine motor skills
timeFrame: 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.
measure: Change in gross motor manual dexterity
timeFrame: 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.
measure: Change in functional independence to perform activities of daily living
timeFrame: 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.
measure: Change in the ability to perform instrumental activities of daily living
timeFrame: 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.
measure: Change in cognitive function
timeFrame: 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.
measure: Change in physical, mental and social healths aspects related to quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Asociación Mostoleña de Esclerosis Múltiple (AMDEM)
state: Madrid
city: Madrid
country: Spain
facility: Fundación Esclerosis Multiple Madrid (FEMM)
Study officials:
References: