Clinical trial NCT05870254: Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)
Official title: Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Physical Therapy
Exercise
Virtual Reality Exposure Therapy
Rehabilitation
Lead sponsor: University of Vigo
Sponsor class: OTHER
Collaborators: name: Asociación Viguesa de Esclerosis Múltiple de Pontevedra
First posted: 2023-05-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Balance, gait and risk of falling
timeFrame: pre-intervention
measure: Balance, gait and risk of falling
timeFrame: immediately after the intervention
measure: Balance, gait and risk of falling
timeFrame: 4 weeks after the intervention
measure: functional autonomy
timeFrame: pre-intervention
measure: functional autonomy
timeFrame: immediately after the intervention
measure: functional autonomy
timeFrame: 4 weeks after the intervention
measure: functional and cognitive autonomy
timeFrame: pre-intervention
measure: functional and cognitive autonomy
timeFrame: immediately after the intervention
measure: functional and cognitive autonomy
timeFrame: 4 weeks after the intervention
measure: functional mobility and lower limb strength
timeFrame: pre-intervention
measure: functional mobility and lower limb strength
timeFrame: immediately after the intervention
measure: functional mobility and lower limb strength
timeFrame: 4 weeks after the intervention
measure: Reaction Time
timeFrame: pre-intervention
measure: Reaction Time
timeFrame: immediately after the intervention
measure: Reaction Time
timeFrame: 4 weeks after the intervention
measure: Fatigue
timeFrame: pre-intervention
measure: Fatigue
timeFrame: immediately after the intervention
measure: Fatigue
timeFrame: 4 weeks after the intervention
Secondary outcomes:
measure: Safety of the IVR intervention
timeFrame: immediately after the intervention
measure: Usability of the IVR intervention
timeFrame: immediately after the intervention
measure: Satisfaction and experiences post IVR intervention
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: University of Vigo
state: Galicia
city: Pontevedra
country: Spain
facility: University of Vigo
Study officials:
References: