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

RecruitingNot a drug-phase studyMS (type not specified)NCT06735053

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Virtual Reality group

Placebo

  • Placebo virtual reality group

What it measured

Main measures

  • 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.

    Thinking and memoryFatigue

Other measures (7)

  • 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.

    Thinking and memoryQuality of life (reported by participants)
  • 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.

    Arm and hand function
  • 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.

    Arm and hand function
  • 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.

    Walking and mobilityBladder, bowel and sexual function
  • 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.

    Bladder, bowel and sexual function
  • 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.

    Thinking and memory
  • 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.

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 70

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Feb 2025

    2. Main results due

      May 2025

    3. Finished

      Jul 2025

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