The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With MS

NCT06987994 | Completed

• 1 other identifier: VRMS2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the effectiveness of virtual reality (VR) as a complementary intervention to traditional physical therapy for individuals diagnosed with Multiple Sclerosis (MS). MS is a chronic neurological condition that affects motor and cognitive functions, with fatigue being one of the most common and disabling symptoms. This study will assess whether the use of VR-based applications, in addition to standard physiotherapy, can reduce fatigue and improve functional capacity in individuals with MS. Participants will be randomly assigned to two groups: one group will receive conventional physiotherapy only, while the other will receive VR-based therapy alongside physiotherapy. The intervention period will last four weeks, and both groups will be evaluated using standardized outcome measures before and after the intervention. These include the Fatigue Severity Scale (FSS), the Timed Up and Go (TUG) test, and the 6-Minute Walk Test (6MWT). The study is designed to address a gap in current literature, as no prior research has specifically examined the impact of virtual reality on fatigue and functional performance in MS patients. The findings may provide valuable insights into innovative rehabilitation strategies that enhance patient outcomes and improve quality of life.

Conditions

Multiple Sclerosis; Multiple Sclerosis (MS) - Relapsing-remitting; Virtual Reality

Keywords

multiple sclerosis; virtual reality; fatigue; functional capacity; physical therapy

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Score (FSS)

  Fatigue will be assessed using the Fatigue Severity Scale (FSS), a validated questionnaire consisting of 9 items scored on a 7-point Likert scale. The scale measures the impact of fatigue on daily functioning and is widely used in MS populations to evaluate changes in perceived fatigue.

  Baseline and after 4 weeks of intervention

Secondary Outcomes (1)

• Timed Up and Go Test (TUG)

  Baseline and after 4 weeks of intervention

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

In this group the number of Participants are 15 . The experment by using VR sessions will last 30 minutes per session, 3 times per week for 4 weeks . In addition to the same physiotherapy program used in the control group, this group will receive Virtual Reality (VR) training using a Meta Quest 2 headset . Patients will interact with immersive environments designed to stimulate movement and functional tasks.

Other: Experemental group

conventional physica ltherapy

ACTIVE COMPARATOR

Participants will receive conventional physiotherapy 3 times per week for 4 weeks. The treatment includes:Standing exercises: multidirectional stepping, single- and double-leg stance .Walking exercises: forward, backward, and lateral walking.Weight-shifting exercises: lunges, half-squats, leaning, and reaching,and the participent will be also 15 pateint

Other: control group( physical therapy)

Interventions

control group( physical therapy) OTHER

Participants will receive conventional physiotherapy 3 times per week for 4 weeks. The treatment includes: Standing exercises: multidirectional stepping, single- and double-leg stance Walking exercises: forward, backward, and lateral walking Weight-shifting exercises: lunges, half-squats, leaning, and reaching

conventional physica ltherapy

Experemental group OTHER

In this group the number of Participants are 15 . The experment by using VR sessions will last 30 minutes per session, 3 times per week for 4 weeks . In addition to the same physiotherapy program used in the control group, this group will receive Virtual Reality (VR) training using a Meta Quest 2 headset . Patients will interact with immersive environments designed to stimulate movement and functional tasks.

Also known as: Virtual Rrality

Virtual Reality group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals diagnosed as MS by a physician
• Expanded Disability Status Scale (EDSS): 2.0-6.5
• Patient able to walk with or without the use of unilateral support (e.g., a cane)
• Patient had not experienced a severe exacerbation of symptoms requiring medical intervention in the previous month
• subjects had to have the cognitive capacity to assure the requisite cognitive ability
• spasticity up to 2 on Ashworth scale.

You may not qualify if:

• \. cognitive disorders hampering the execution of the exercises/assessment, 2. Ability to maintain monopodalic-standing position for 10 s 3. cardiovascular disorders 4. orthopedic disorders that could negatively affect balance 5. uncorrected visual or auditory impairments 6. pregnancy

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: December 1, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 28, 2025
• Last Updated: May 23, 2025

Record last verified: 2024-11

Locations

TU (1)