Multiple SclerosisVRMSNCT06987994
The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With MS
A study testing Experemental group in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Virtual Reality
- What is being tested?
- Experemental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Istanbul
About this study
Official title: The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With Multiple Sclerosis
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.
- Being tested
- control group( physical therapy), Experemental group
- Keywords
- multiple sclerosis, virtual reality, fatigue, functional capacity, physical therapy
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 groupOther
Also called Virtual Rrality
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: control group( physical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (1)
Timed Up and Go Test (TUG)
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.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Dec 2024
- Primary completion18 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987994
- Sponsor's protocol ID
- VRMS2025
- Acronym
- VRMS
- Status last verified
- Nov 2024
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Fatigue and Functional Capacity in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06987994
- Acronym / sponsor ID
- VRMS / VRMS2025
- Keywords
- multiple sclerosis, virtual reality, fatigue, functional capacity, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Other: Experemental groupIn 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 | Active comparator | Other: 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,and the participent will be also 15 pateint |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | conventional physica ltherapy |
| Experemental groupAlso: Virtual RralityIn 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 | Virtual Reality group |
Primary outcome
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.
1 secondary outcome
Timed Up and Go Test (TUG)
Time frame: Baseline and after 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experemental group in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Score (FSS) (time frame: Baseline and after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.