Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM) (ExeRVIEM)
Primary Purpose
Multiple Sclerosis, Physical Therapy, Exercise
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ExeRVIEM Program
Usual center program
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis
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.
Sites / Locations
- Pablo Campo-Prieto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ExeRVIEM Protocol
Usual Protocol
Arm Description
They will carry out the ExeRVIEM program for 8 weeks (2 times a week). Intervention based on exercise therapies with RVI software.
They will carry out the usual protocol of Association
Outcomes
Primary Outcome Measures
Balance, gait and risk of falling
TINETTI TEST
Balance, gait and risk of falling
TINETTI TEST
Balance, gait and risk of falling
TINETTI TEST
functional autonomy
TIMED UP GO
functional autonomy
TIMED UP GO
functional autonomy
TIMED UP GO
functional and cognitive autonomy
TIMED UP GO COGNITIVE
functional and cognitive autonomy
TIMED UP GO COGNITIVE
functional and cognitive autonomy
TIMED UP GO COGNITIVE
functional mobility and lower limb strength
Five Times Sit to Stand Test
functional mobility and lower limb strength
Five Times Sit to Stand Test
functional mobility and lower limb strength
Five Times Sit to Stand Test
Reaction Time
SOFTWARE REZZIL
Reaction Time
SOFTWARE REZZIL
Reaction Time
SOFTWARE REZZIL
Fatigue
The Fatigue Severity Scale
Fatigue
The Fatigue Severity Scale
Fatigue
The Fatigue Severity Scale
Secondary Outcome Measures
Safety of the IVR intervention
Simulator Sickness Questionnaire
Usability of the IVR intervention
System Usability Scale
Satisfaction and experiences post IVR intervention
Game Experience Questionnaire-POST GAME MODULE
Full Information
NCT ID
NCT05870254
First Posted
March 22, 2023
Last Updated
May 11, 2023
Sponsor
University of Vigo
Collaborators
Asociación Viguesa de Esclerosis Múltiple de Pontevedra
1. Study Identification
Unique Protocol Identification Number
NCT05870254
Brief Title
Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)
Acronym
ExeRVIEM
Official Title
Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo
Collaborators
Asociación Viguesa de Esclerosis Múltiple de Pontevedra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Physical Therapy, Exercise, Virtual Reality Exposure Therapy, Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ExeRVIEM Protocol
Arm Type
Experimental
Arm Description
They will carry out the ExeRVIEM program for 8 weeks (2 times a week). Intervention based on exercise therapies with RVI software.
Arm Title
Usual Protocol
Arm Type
Active Comparator
Arm Description
They will carry out the usual protocol of Association
Intervention Type
Other
Intervention Name(s)
ExeRVIEM Program
Intervention Description
Virtual exercise based program
Intervention Type
Other
Intervention Name(s)
Usual center program
Intervention Description
Usual center cares
Primary Outcome Measure Information:
Title
Balance, gait and risk of falling
Description
TINETTI TEST
Time Frame
pre-intervention
Title
Balance, gait and risk of falling
Description
TINETTI TEST
Time Frame
immediately after the intervention
Title
Balance, gait and risk of falling
Description
TINETTI TEST
Time Frame
4 weeks after the intervention
Title
functional autonomy
Description
TIMED UP GO
Time Frame
pre-intervention
Title
functional autonomy
Description
TIMED UP GO
Time Frame
immediately after the intervention
Title
functional autonomy
Description
TIMED UP GO
Time Frame
4 weeks after the intervention
Title
functional and cognitive autonomy
Description
TIMED UP GO COGNITIVE
Time Frame
pre-intervention
Title
functional and cognitive autonomy
Description
TIMED UP GO COGNITIVE
Time Frame
immediately after the intervention
Title
functional and cognitive autonomy
Description
TIMED UP GO COGNITIVE
Time Frame
4 weeks after the intervention
Title
functional mobility and lower limb strength
Description
Five Times Sit to Stand Test
Time Frame
pre-intervention
Title
functional mobility and lower limb strength
Description
Five Times Sit to Stand Test
Time Frame
immediately after the intervention
Title
functional mobility and lower limb strength
Description
Five Times Sit to Stand Test
Time Frame
4 weeks after the intervention
Title
Reaction Time
Description
SOFTWARE REZZIL
Time Frame
pre-intervention
Title
Reaction Time
Description
SOFTWARE REZZIL
Time Frame
immediately after the intervention
Title
Reaction Time
Description
SOFTWARE REZZIL
Time Frame
4 weeks after the intervention
Title
Fatigue
Description
The Fatigue Severity Scale
Time Frame
pre-intervention
Title
Fatigue
Description
The Fatigue Severity Scale
Time Frame
immediately after the intervention
Title
Fatigue
Description
The Fatigue Severity Scale
Time Frame
4 weeks after the intervention
Secondary Outcome Measure Information:
Title
Safety of the IVR intervention
Description
Simulator Sickness Questionnaire
Time Frame
immediately after the intervention
Title
Usability of the IVR intervention
Description
System Usability Scale
Time Frame
immediately after the intervention
Title
Satisfaction and experiences post IVR intervention
Description
Game Experience Questionnaire-POST GAME MODULE
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pablo Campo-Prieto
City
Pontevedra
State/Province
Galicia
ZIP/Postal Code
36005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exergaming With Immersive Virtual Reality For People With Multiple Sclerosis (ExeRVIEM)
We'll reach out to this number within 24 hrs