Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05870254

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • ExeRVIEM Program

Given to everyone in the trial

  • Usual center program

What it measured

Main measures

  • Balance, gait and risk of falling

    pre-intervention

    Walking and mobility
  • Balance, gait and risk of falling

    immediately after the intervention

    Walking and mobility
  • Balance, gait and risk of falling

    4 weeks after the intervention

    Walking and mobility
  • functional autonomy

    pre-intervention

  • functional autonomy

    immediately after the intervention

  • functional autonomy

    4 weeks after the intervention

  • functional and cognitive autonomy

    pre-intervention

    Thinking and memory
  • functional and cognitive autonomy

    immediately after the intervention

    Thinking and memory
  • functional and cognitive autonomy

    4 weeks after the intervention

    Thinking and memory
  • functional mobility and lower limb strength

    pre-intervention

    Walking and mobilityPhysical function
  • functional mobility and lower limb strength

    immediately after the intervention

    Walking and mobilityPhysical function
  • functional mobility and lower limb strength

    4 weeks after the intervention

    Walking and mobilityPhysical function
  • Reaction Time

    pre-intervention

  • Reaction Time

    immediately after the intervention

  • Reaction Time

    4 weeks after the intervention

  • Fatigue

    pre-intervention

    Fatigue
  • Fatigue

    immediately after the intervention

    Fatigue
  • Fatigue

    4 weeks after the intervention

    Fatigue

Other measures (3)

  • Safety of the IVR intervention

    immediately after the intervention

    Safety
  • Usability of the IVR intervention

    immediately after the intervention

  • Satisfaction and experiences post IVR intervention

    immediately after the intervention

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* People diagnosed with MS belonging to the AVEMPO VIGO Association * Ages between 18-65 years * Ability to stay on your feet and follow the intervention protocol and scheduled assessments

Exclusion criteria

* Medical report that advises against the practice of physical activity and exercise * Uncontrolled outbreak of the disease * Dizziness, vertigo or severe visual impairment.

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

About this trial

In the sponsor's words

TITLE: Exergaming with Immersive Virtual Reality for people with Multiple Sclerosis INTRO: Multiple Sclerosis (MS) is an autoimmune and chronic neurodegenerative pathology caused by loss of the myelin sheath in the nervous system, causing motor, cognitive, behavioral and sensory symptoms. Conventional physiotherapy often includes exercise therapies, based on repetitive performances that can sometimes be unmotivating for patients. Immersive Virtual Reality could offer programs based on exercise (exergames) that are motivating, as well as appropriate to the therapeutic objectives of the target group. This tool has already been successfully tested in other groups (post stroke, Parkinson's,...) with promising results. Our ExeRVIEM project (Exergaming with Immersive Virtual Reality in Multiple Sclerosis) represents a new strategy to improve functionality in people with MS, using an exercise program with Virtual Reality glasses. HYPOTHESIS: The practice of the ExeRVIEM protocol based on physical function training in people with MS contributes to the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy. GENERAL OBJECTIVES: 1.1 Design and implement an ExeRVIEM exercise program/protocol to improve balance in older people 1.2 Analyze the effects of this ExeRVIEM program/protocol, in the short and medium term in people who attend an Association of patients. 1.3 Identify if there is a relationship between the variables that induce frailty and functional dependence and the ExeRVIEM protocol. SPECIFIC OBJECTIVES: 2.1 Determine and apply the ExeRVIEM protocol to explore differential effects for 6 minutes a day (2 days a week for 8 weeks). 2.1.1 Improving the functional independence and mobility of people by improving balance, reducing the risk of falls and the correct development of activities of daily living. 2.1.2 Gait improvement. 2.1.3 Improved functionality. 2.1.4 Improving grip strength. 2.1.5 Improving reaction times. 2.1.6 Improving the perception of fatigue 2.2 Determine the influence of parameters related to exposure to RVI. 2.2.1 Safety of the virtual reality exhibition 2.2.2 Usability of the virtual reality exhibition 2.2.3 Personal experiences and satisfaction of the virtual reality exhibition METHODS: Design: Randomized controlled trial. People diagnosed with MS who attend the AVEMPO VIGO center in Spain on a regular basis will be invited to participate in the study. After they meet the selection criteria, they will be assigned to an experimental group and a control group. Information on the sociodemographic characteristics and a clinical history of the participants will be collected. Intervention: Two groups (experimental and control). The experimental group will carry out the ExeRVIEM protocol sessions (6 min) focused on the upper and lower limbs. (2 sessions per week for 8 weeks). All sessions will begin with a warm-up focused on stimulating coordination and joint mobilization, so that the body is predisposed both centrally and peripherally to carry out the session and will end with a stretching routine accompanied by breathing calm and controlled cycles. The session will be supervised by the center's physiotherapist or occupational therapist. The control group will continue with the usual activities proposed by the center team. Evaluations: 3 evaluations will be carried out: initial, final (at 8 weeks) and follow-up (one month after the end of the program). The contents of the evaluations will be: Patient characteristics: "Ad hoc" record sheet that will include data on age, sex, years since diagnosis, MS subtype, and drug treatment. 1. ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook) 2. Balance, gait and risk of falling (Tinetti Test) 3. Functional mobility and lower limb strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test- simple and cognitive) 5. Fatigue (Fatigue Severity Scale) 6 Handgrip (dynamometer) 7. Reaction time (Rezzil Software) Hypothesis: Our findings aim to support the use of new health technologies in the field of rehabilitation and medical care for people with MS, achieving a feasible and safe Immersive Virtual Reality exergaming program.

Papers

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    History

      1. Started

        Jan 2024

      2. Main results due

        Mar 2024

      3. Finished

        Mar 2024

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