Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS) [Срок оценки: 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.]

Вторичные конечные точки (7)

• Change in Physical and psicological impact of Multiple Sclerosis on patients'life measured with Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

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

Идентификаторы

NCT: NCT06735053 · 24/765-EC_P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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