Clinical trial NCT06987994: The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With MS
Official title: The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis (MS) - Relapsing-remitting
Virtual Reality
Keywords: multiple sclerosis
virtual reality
fatigue
functional capacity
physical therapy
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fatigue Severity Score (FSS)
timeFrame: Baseline and after 4 weeks of intervention
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: Baseline and after 4 weeks of intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Study officials:
References: