Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis

NCT07543900 | Completed

• 1 other identifier: HEALTHYFIT-UVIGO 1/2026
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

TITLE: Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis INTRODUCTION: Multiple sclerosis (MS) is a chronic neuroimmunological and degenerative disease characterized by demyelination within the central nervous system. Its clinical course involves motor impairment, sensory disturbances, cognitive dysfunction, and a progressive decline in functional independence. MS is one of the leading causes of non-traumatic disability in young adults. This highlights the considerable impact of the disease, both in terms of healthcare burden and healthcare expenditure. Within this context, therapeutic exercise has evolved from being considered potentially harmful to being recognized as a safe and effective intervention capable of improving gait, balance, cardiorespiratory fitness, fatigue, and quality of life in people with MS. A model has been proposed for prescribing and progressing exercise at different stages of MS: passive range-of-motion exercises designed for patients with the most severe symptoms, a second stage incorporating active muscle-strengthening exercises, and finally, integrated exercise programs that incorporate strength, endurance, balance, and coordination training. Evidence from systematic reviews and meta-analyses shows that structured exercise (including high-intensity protocols when performed under supervision) is safe and can improve functional outcomes. Our ExeRVIEM II project (High-Intensity Exercise Program with Immersive Virtual Reality in Multiple Sclerosis) represents a novel strategy to facilitate rehabilitation exercise programs using head-mounted virtual reality displays. HYPOTHESIS: The ExeRVIEM II project, based on training physical function in people with MS, is feasible and safe, and could have a potential clinical impact in the motor and cognitive domains, as well as applicability in community settings, such as patient associations. GENERAL OBJECTIVES: 1.1 To design and implement an ExeRVIEM II exercise program/protocol for people with MS. 1.2 To evaluate the feasibility and safety of the high-intensity virtual reality exercise program. SPECIFIC OBJECTIVES: 2.1 To analyze the possible changes in disability, functional variables, cognitive domains and biomarkers in the short and medium term in people who attend a patient association and carry out the ExeRVIEM II exercise program/protocol for people with MS. METHODOLOGY: An exploratory, pre-feasibility, single-arm, single-cohort study will be conducted at the AVEMPO patient association (Vigo, Spain). The intervention will consist of an 8-week supervised virtual rehabilitation program, with two weekly sessions on alternate days, in addition to the standard rehabilitation prescribed by the AVEMPO clinical team (physiotherapy, occupational therapy, and cognitive training sessions). An inmersive virtual reality (IVR) boxing exercise videogame will be used, administered via a virtual reality headset. In accordance with clinical guidelines for IVR, and given the exploratory nature of the study, sessions will be intentionally brief (10 minutes) to minimize cybersickness and excessive fatigue. Assessments will be conducted at baseline (week 0) and immediately after the intervention (week 8). Demographic and clinical data will also be collected, including sex, age, comorbidities, disease duration, MS subtype, and pharmacological treatment. Assessments will be conducted at the patient association and in the Neurology Department of the referral hospital. Feasibility and safety assessments will be performed at the patient association by the supervising physiotherapist, while the remaining assessments will be completed at the hospital by a neurologist specializing in MS (without blinding due to the single-group design and small setting). The content of the assessments will be: Patient characteristics: an ad hoc registration form that will include data on age, sex, years since diagnosis, MS subtype, and pharmacological treatment. Feasibility: Number of virtual sessions attended by each participant (adherence rate via registration sheet). Rate Perceived Effort using the modified Borg scale, which measures the level of perceived exertion on a scale of 0 to 10 from no effort to maximum effort. Usability of the virtual tool using the Sistem Usability Scale (SUS) range 0-100. Safety: adverse events (side effects related to virtual reality exposure) using the Simulator Sickness Questionnaire (SSQ). Level o disability: using the Expanded Disability Status Scale (EDSS). Gait will be evaluated using the 25Foot Walk Test (25FWT). Manual dexterity will be assessed using by 9-Hole Peg Test (9HPT). Cognitive domains evaluated by the Symbol Digit Modalities Test (SDMT) Axonal injury biomarker evaluated by Neurofilament light chain (sNfL) concentrations

Conditions

Exercise (EX); Virtual Reality Exposure Therapy; Rehabilitation Exercise; Multiple Sclerosis; Physical Therapy

Outcome Measures

Primary Outcomes (4)

• Adverse events linked to virtual reality exposure assessed by the Simulator Sickness Questionnaire (SSQ).

  SSQ assess the IVR exposure by evaluating potential associated symptoms in three broad domains: 1. oculomotor symptoms; 2. disorientation; 3. nausea. Each item is rated on a four-point scale (0 = feel nothing; 1 = a little; 2 = moderately; and 3 = very much) and the total score (maximum of 48 points) is the sum of the scores of the three subscales.

  Week 8

• Usability of the virtual tool assessed by System Usability Scale (SUS).

  SUS consists of ten questions on a Likert-type scale. Each question is scored from 1 to 5 based on the degree of agreement or disagreement with each statement, where 5 means strongly agree and 1 means strongly disagree. The algorithm resulting from these responses generates a maximum score of 100 points.

  Week 8

• Number of virtual sessions attended by each participant

  Adherence rate via registration sheet

  up to 8 weeks

• Rate perceived effort (RPE) evaluated by the modified Borg scale.

  The modified Borg scale and which measures the RPE on a scale of 0-10 from no exertion (0) to the greatest possible exertion (10).

  up to 8 weeks

Secondary Outcomes (10)

• Level of disability using the Expanded Disability Status Scale (EDSS)

  Baseline

• Level of disability using the Expanded Disability Status Scale (EDSS)

  Week 8

• Gait evaluated by 25Foot Walk Test (25FWT)

  Baseline

• Gait evaluated by 25Foot Walk Test (25FWT)

  Week 8

• Manual dexterity assessed by 9-Hole Peg Test (9HPT)

  Baseline

Study Arms (1)

Experimental: ExeRVIEM II Protocol

EXPERIMENTAL

Virtual exercise based program

Other: Virtual exercise based program

Interventions

Virtual exercise based program OTHER

The intervention will consist of a supervised virtual rehabilitation program delivered over 8 weeks, with two sessions per week on alternating days, in addition to the standard rehabilitation prescribed by the AVEMPO clinical team (physiotherapy, occupational therapy and cognitive training sessions). An Immersive Virtual Reality boxing-based exergame executed through a VR headset will be used.

Experimental: ExeRVIEM II Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age.
• Confirmed diagnosis of MS.
• Stable disease with no relapse in the previous 6 weeks.
• Patients who will be take follow up by a neurologist at the referall hospital and will be members of AVEMPO.
• Ability to perform moderate exercise.
• Capacity to provide informed consent.

You may not qualify if:

• Comorbidities that hinder the development of the VR program
• Visual or vestibular impairment that would contraindicate VR use.
• Recent changes in disease modifying therapy.

Sponsors & Collaborators

• University of Vigo: lead
• Hospital Álvaro Cunqueiro: collaborator
• Complejo Hospitalario Universitario de Santiago: collaborator
• Asociación Viguesa de Esclerosis Múltiple de Pontevedra: collaborator

Study Sites (1)

University of Vigo

Vigo, Pontevedra, 36316, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Pablo Campo Prieto, PhD

  University of Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: March 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)