Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)

Multiple Sclerosis Clinical Trial

— ExeRVIEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870254
• Other study ID #: HEALTHYFIT-UVIGO 1/2023
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: March 29, 2024

Study information

• Verified date: January 2024
• Source: University of Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 29, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Multiple Sclerosis
• Physical Therapy
• Rehabilitation
• Sclerosis
• Virtual Reality Exposure Therapy

Intervention

Other:
• ExeRVIEM Program
Virtual exercise based program
• Usual center program
Usual center cares

Locations

Country	Name	City	State
Spain	University of Vigo	Pontevedra	Galicia
Spain	University of Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
University of Vigo	Asociación Viguesa de Esclerosis Múltiple de Pontevedra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance, gait and risk of falling	TINETTI TEST	pre-intervention
Primary	Balance, gait and risk of falling	TINETTI TEST	immediately after the intervention
Primary	Balance, gait and risk of falling	TINETTI TEST	4 weeks after the intervention
Primary	functional autonomy	TIMED UP GO	pre-intervention
Primary	functional autonomy	TIMED UP GO	immediately after the intervention
Primary	functional autonomy	TIMED UP GO	4 weeks after the intervention
Primary	functional and cognitive autonomy	TIMED UP GO COGNITIVE	pre-intervention
Primary	functional and cognitive autonomy	TIMED UP GO COGNITIVE	immediately after the intervention
Primary	functional and cognitive autonomy	TIMED UP GO COGNITIVE	4 weeks after the intervention
Primary	functional mobility and lower limb strength	Five Times Sit to Stand Test	pre-intervention
Primary	functional mobility and lower limb strength	Five Times Sit to Stand Test	immediately after the intervention
Primary	functional mobility and lower limb strength	Five Times Sit to Stand Test	4 weeks after the intervention
Primary	Reaction Time	SOFTWARE REZZIL	pre-intervention
Primary	Reaction Time	SOFTWARE REZZIL	immediately after the intervention
Primary	Reaction Time	SOFTWARE REZZIL	4 weeks after the intervention
Primary	Fatigue	The Fatigue Severity Scale	pre-intervention
Primary	Fatigue	The Fatigue Severity Scale	immediately after the intervention
Primary	Fatigue	The Fatigue Severity Scale	4 weeks after the intervention
Secondary	Safety of the IVR intervention	Simulator Sickness Questionnaire	immediately after the intervention
Secondary	Usability of the IVR intervention	System Usability Scale	immediately after the intervention
Secondary	Satisfaction and experiences post IVR intervention	Game Experience Questionnaire-POST GAME MODULE	immediately after the intervention