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

NCT ID: NCT06987994

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality group

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.

Group Type: EXPERIMENTAL

Experemental group

Intervention Type: 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.

conventional physica ltherapy

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

Group Type: ACTIVE_COMPARATOR

control group( physical therapy)

Intervention Type: 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

Interventions

control group( physical therapy)

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

Intervention Type: OTHER

Experemental group

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.

Intervention Type: OTHER

Other Intervention Names

Virtual Rrality

Eligibility Criteria

Inclusion Criteria

1. individuals diagnosed as MS by a physician

2. Expanded Disability Status Scale (EDSS): 2.0-6.5

3. Patient able to walk with or without the use of unilateral support (e.g., a cane)

4. Patient had not experienced a severe exacerbation of symptoms requiring medical intervention in the previous month

5. subjects had to have the cognitive capacity to assure the requisite cognitive ability

6. spasticity up to 2 on Ashworth scale.

Exclusion Criteria

• 1. 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istinye University Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

VRMS2025

Identifier Type: -

Identifier Source: org_study_id