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Completed

NCT Number: NCT06987994

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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

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.

Other names: Virtual Rrality

Primary outcomes

  1. Fatigue Severity Score (FSS)

    Time frame: Baseline and after 4 weeks of intervention

    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.

Secondary outcomes

  1. Timed Up and Go Test (TUG)

    Time frame: Baseline and after 4 weeks of intervention

    The Timed Up and Go (TUG) test will be used to assess functional mobility and fall risk. Participants will be timed as they rise from a seated position, walk 3 meters, turn, walk back, and sit down again. The time (in seconds) required to complete the task will be recorded. TUG is a validated measure commonly used in individuals with MS to assess gait and mobility status.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Acronym: VRMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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