Multiple SclerosisNCT06721416
Comparing the Acute Effects of Different Exercise Approaches in Patients With Multiple Sclerosis
A study testing Traditional Aerobic Exercise, VR Based Aerobic Exercise and Conventional Exercise in people with Multiple Sclerosis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Traditional Aerobic Exercise, VR Based Aerobic Exercise and Conventional Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Aug 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
- 18-55 years old.
- EDSS score < 4.5
- Mini mental examination test score ≥ 24
- No MS attack in the last 6 months.
- No visual or vestibular deficits.
- Signed the written consent form.
Who cannot join
- Having previous full immersive VR experience.
- Having an additional neurological disease.
- Spasticity in any muscle of the upper extremity > 3, according to MAS.
- Continuing the active physical therapy and rehabilitation program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Acute Effects and Cortical Hemodynamic Response of Different Exercise Approaches in Patients With Multiple Sclerosis: fNIRS Study
Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and increase participation in daily life activities. In this study, it is planned to investigate the acute effects of conservative and virtual reality (VR)-based aerobic exercise applications and standard exercises that frequently form the rehabilitation programs of individuals with MS in clinics. For this purpose, patients with MS who met the inclusion criteria were given two-week intervals; Conservative aerobic exercise, virtual reality-based aerobic exercise and standard exercise practices will be performed. With the data obtained from this study, it is aimed to investigate the safety of aerobic exercises performed using VR tools that can be used in telerehabilitation applications, which are thought to have a very important place in MS rehabilitation in the future, in terms of acute body temperature increase, cognitive and physical fatigue caused by conservative methods and fNIRS cortical effects of VR-based aerobic exercise applications. It will be possible to prove it with objective methods such as.
- Conditions
- Multiple Sclerosis
- Being tested
- Traditional Aerobic Exercise, VR Based Aerobic Exercise, Conventional Exercise
- Keywords
- multiple sclerosis, aerobic exercise, virtual reality, fatigue, cognition
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Aerobic ExerciseOther
Traditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes.
VR Based Aerobic ExerciseOther
In the virtual reality-based aerobic exercise training, the game called "Beat Saber" will be played with Oculus Quest 2 virtual reality for 30 minutes.
Conventional ExerciseOther
The conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Beased | Experimental | VR based aerobic exercise Receives: Other: VR Based Aerobic Exercise |
| Traditional | Experimental | Cycling ergometer based aerobic exercise Receives: Other: Traditional Aerobic Exercise |
| Conventional | Experimental | Conventional physical therapy approaches Receives: Other: Conventional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Spent
Sense Wear Pro3 Armband by Body Media Inc. (USA): It will be used to calculate the energy spent during exercises. This device is a 2-axis monitor with multiple sensors such as a galvanic skin response sensor to evaluate skin electrical resistance changes and a skin temperature sensor to evaluate temperature changes. The device will be worn on the individuals' right arm triceps muscle throughout the exercises and will be used to calculate the energy spent during the exercises.
Measured: For 30 minutes during the entire exercise
Cortical Activity
Functional Near Infrared Light Spectroscopy (fNIRS): fNIRS is an optical system that uses near-infrared (NIR) light in the assessment of brain activity by measuring light absorption differences in changes in oxy-hemoglobin and deoxy-hemoglobin concentrations. The modified Beer-Lambert law is used to convert and calculate light intensity measurements obtained from the brain into hemodynamic changes. Hemodynamic responses that occur with different stimuli in the prefrontal cortex region of the brain can be monitored with these optical systems. In this study, it is planned to measure individuals' prefrontal cortex activations while performing 3 different exercises and a post-exercise cognitive performance test.
Measured: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Body Temperature
Individuals' body temperatures will be measured with the help of an electronic digital thermometer before and after the exercises.
Measured: immediately before the exercise, immediately after the exercise
Electrodermal Activity
Electrodermal activity data will be recorded with the Shimmer device to be used to determine the stress levels of the patients.
Measured: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Cognitive Function
Stroop test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Measured: Immediately before the exercise, immediately after the exercise
Cognitive Function
2-back test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Measured: Immediately before the exercise, immediately after the exercise
Cognitive Function
Symbol Digit Modalities Test will be used after the exercise to evaluate cognitive performance.
Measured: Immediately after the exercise
Physical Fatigue
Modified Borg Scale will be used after the exercise to evaluate subjective physical fatigue. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
Measured: Immediately after the exercise
Satisfaction Level satisfaction level Satisfaction Level
It will be evaluated with the Satisfaction Evaluation Survey of Virtual Rehabilitation Systems. The total score range in this survey varies between 6-30, with higher scores being associated with higher satisfaction.
Measured: Immediately after the exercise
Late-term fatigue
One day after the exercises, patients will be questioned by phone about whether they have arm pain, and in case of pain, they will be asked to score the severity of pain according to Modified Borg Scale. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
Measured: 24 hours later after the exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Aug 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 Acibadem 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sevik Dönderici, Acibadem University
- Investigators
- Merve Sevik Dönderici, MSc, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721416
- Sponsor's protocol ID
- 2023-07/229
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2024
- Last updated
- 17 Sep 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Acute Effects and Cortical Hemodynamic Response of Different Exercise Approaches in Patients With Multiple Sclerosis: fNIRS Study
- ClinicalTrials.gov ID
- NCT06721416
- Acronym / sponsor ID
- 2023-07/229
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, aerobic exercise, virtual reality, fatigue, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 6 Dec 2024 (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.
Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and increase participation in daily life activities. In this study, it is planned to investigate the acute effects of conservative and virtual reality (VR)-based aerobic exercise applications and standard exercises that frequently form the rehabilitation programs of individuals with MS in clinics. For this purpose, patients with MS who met the inclusion criteria were given two-week intervals; Conservative aerobic exercise, virtual reality-based aerobic exercise and standard exercise practices will be performed. With the data obtained from this study, it is aimed to investigate the safety of aerobic exercises performed using VR tools that can be used in telerehabilitation applications, which are thought to have a very important place in MS rehabilitation in the future, in terms of acute body temperature increase, cognitive and physical fatigue caused by conservative methods and fNIRS cortical effects of VR-based aerobic exercise applications. It will be possible to prove it with objective methods such as.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Beased | Experimental | Other: VR Based Aerobic ExerciseVR based aerobic exercise |
| Traditional | Experimental | Other: Traditional Aerobic ExerciseCycling ergometer based aerobic exercise |
| Conventional | Experimental | Other: Conventional ExerciseConventional physical therapy approaches |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
- 18-55 years old.
- EDSS score < 4.5
- Mini mental examination test score ≥ 24
- No MS attack in the last 6 months.
Key exclusion criteria (4 listed)
- Having previous full immersive VR experience.
- Having an additional neurological disease.
- Spasticity in any muscle of the upper extremity > 3, according to MAS.
- Continuing the active physical therapy and rehabilitation program.
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 |
|---|---|---|
| Traditional Aerobic ExerciseTraditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes. | Other | Traditional |
| VR Based Aerobic ExerciseIn the virtual reality-based aerobic exercise training, the game called "Beat Saber" will be played with Oculus Quest 2 virtual reality for 30 minutes. | Other | Virtual Reality Beased |
| Conventional ExerciseThe conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants. | Other | Conventional |
Primary outcome
Energy Spent
Time frame: For 30 minutes during the entire exercise
Sense Wear Pro3 Armband by Body Media Inc. (USA): It will be used to calculate the energy spent during exercises. This device is a 2-axis monitor with multiple sensors such as a galvanic skin response sensor to evaluate skin electrical resistance changes and a skin temperature sensor to evaluate temperature changes. The device will be worn on the individuals' right arm triceps muscle throughout the exercises and will be used to calculate the energy spent during the exercises.
Cortical Activity
Time frame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Functional Near Infrared Light Spectroscopy (fNIRS): fNIRS is an optical system that uses near-infrared (NIR) light in the assessment of brain activity by measuring light absorption differences in changes in oxy-hemoglobin and deoxy-hemoglobin concentrations. The modified Beer-Lambert law is used to convert and calculate light intensity measurements obtained from the brain into hemodynamic changes. Hemodynamic responses that occur with different stimuli in the prefrontal cortex region of the brain can be monitored with these optical systems. In this study, it is planned to measure individuals' prefrontal cortex activations while performing 3 different exercises and a post-exercise cognitive performance test.
Body Temperature
Time frame: immediately before the exercise, immediately after the exercise
Individuals' body temperatures will be measured with the help of an electronic digital thermometer before and after the exercises.
Electrodermal Activity
Time frame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Electrodermal activity data will be recorded with the Shimmer device to be used to determine the stress levels of the patients.
Cognitive Function
Time frame: Immediately before the exercise, immediately after the exercise
Stroop test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Cognitive Function
Time frame: Immediately before the exercise, immediately after the exercise
2-back test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Cognitive Function
Time frame: Immediately after the exercise
Symbol Digit Modalities Test will be used after the exercise to evaluate cognitive performance.
Physical Fatigue
Time frame: Immediately after the exercise
Modified Borg Scale will be used after the exercise to evaluate subjective physical fatigue. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
Satisfaction Level satisfaction level Satisfaction Level
Time frame: Immediately after the exercise
It will be evaluated with the Satisfaction Evaluation Survey of Virtual Rehabilitation Systems. The total score range in this survey varies between 6-30, with higher scores being associated with higher satisfaction.
Late-term fatigue
Time frame: 24 hours later after the exercise
One day after the exercises, patients will be questioned by phone about whether they have arm pain, and in case of pain, they will be asked to score the severity of pain according to Modified Borg Scale. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
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 17 Sep 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.
Merve Sevik Dönderici, MSc principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Aerobic Exercise, VR Based Aerobic Exercise and Conventional Exercise in people with Multiple Sclerosis, run by Acibadem 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 7 inclusion and 4 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 17 Sep 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?
Energy Spent (time frame: For 30 minutes during the entire exercise). The study lists 10 primary outcomes in all. 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 17 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.