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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- European University of Madrid
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Marina Castel Sánchez
PhD
European University of Madrid
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.
Outcomes
Primary Outcomes
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.
Modified Fatigue Impact Scale is a self-report questionnaire designed to assess the impact of fatigue on patients with multiple sclerosis (MS). It evaluates how fatigue affects physical, cognitive, and psychosocial functioning on daily life in MS patients. The MFIS consists of 21 items divided into three subscales: physical, cognitive, and psychosocial. Higher scores indicate a greater impact of fatigue. The total score is the sum of all item scores, with subscale scores calculated separately. The administration time is approximately 5-10 minutes. It is typically self-administered, but can be conducted as an interview if necessary.
Secondary Outcomes
- Change in Physical and psicological impact of Multiple Sclerosis on patients'life measured with Multiple Sclerosis Impact Scale (MSIS-29)(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(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(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(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(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(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(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.)