ExeRVIEM Program
OtherVirtual exercise based program
NCT Number: NCT05870254
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
University of Vigo, Pontevedra, Galicia, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Virtual exercise based program
Usual center cares
Time frame: pre-intervention
TINETTI TEST
Time frame: immediately after the intervention
TINETTI TEST
Time frame: 4 weeks after the intervention
TINETTI TEST
Time frame: pre-intervention
TIMED UP GO
Time frame: immediately after the intervention
TIMED UP GO
Time frame: 4 weeks after the intervention
TIMED UP GO
Time frame: pre-intervention
TIMED UP GO COGNITIVE
Time frame: immediately after the intervention
TIMED UP GO COGNITIVE
Time frame: 4 weeks after the intervention
TIMED UP GO COGNITIVE
Time frame: pre-intervention
Five Times Sit to Stand Test
Time frame: immediately after the intervention
Five Times Sit to Stand Test
Time frame: 4 weeks after the intervention
Five Times Sit to Stand Test
Time frame: pre-intervention
SOFTWARE REZZIL
Time frame: immediately after the intervention
SOFTWARE REZZIL
Time frame: 4 weeks after the intervention
SOFTWARE REZZIL
Time frame: pre-intervention
The Fatigue Severity Scale
Time frame: immediately after the intervention
The Fatigue Severity Scale
Time frame: 4 weeks after the intervention
The Fatigue Severity Scale
Time frame: immediately after the intervention
Simulator Sickness Questionnaire
Time frame: immediately after the intervention
System Usability Scale
Time frame: immediately after the intervention
Game Experience Questionnaire-POST GAME MODULE
University of Vigo
Other
Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
Acronym: ExeRVIEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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