Multiple SclerosisNCT06107023
Action Observation Training With 3D Virtual Reality in Patients With Multiple Sclerosis
A study testing Action observation training in people with Multiple Sclerosis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis is a chronic, autoimmune and inflammatory disease of the Central Nervous System characterized by neuronal demyelination and axonal degeneration. Upper extremity problems are present in MS patients from an early stage, affecting the performance of the individual and leading to a decrease in activity… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Action observation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 2 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- < 2 years MS diagnosis according to McDonald criteria
- between 3.5 and 6 the EDSS
- Nine Hole Peg Test > 30s for at least one upper extremity
- no change in medication in the last 6 months
- having MS disease with ongoing attacks
- >2 Modified Ashworth Scale in the upper extremities
- MOCA>25
Who cannot join
- diagnosed with neurological (except MS), cardiopulmonary, metabolic or musculoskeletal disease that would prevent treatment and evaluation
- receiving botulinum toxin treatment in the last 6 months
- visual impairment uncorrected by optical devices
- inability to adapt to treatment based on 3D immersive virtual reality (e.g. with cognitive impairment, communication problems, psychological problems or vestibular system problems)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Action Observation Training With 3D Virtual Reality on Upper Extremity Functions in Patients With Multiple Sclerosis With Attacks
Multiple sclerosis is a chronic, autoimmune and inflammatory disease of the Central Nervous System characterized by neuronal demyelination and axonal degeneration. Upper extremity problems are present in MS patients from an early stage, affecting the performance of the individual and leading to a decrease in activity of daily living ability in proportion to the extent of the problem. Action Observation Training is currently being examined as one of the methods used for the improvement of motor disorders and has been shown in the literature to be effective on different functions in neurological diseases.
The aim of this study was to investigate the effects of action observation training with 3D virtual reality on upper extremity functions, fatigue, cognitive functions, activities of daily living and quality of life in MS patients.
Read more
Hypothesis 1: Action observation training with 3D virtual reality has an effect on upper extremity functions in MS patients.
Hypothesis 2: Action observation training with 3D virtual reality has an effect on cognitive function in MS patients.
Hypothesis 3: Action observation training with 3D virtual reality has an effect on fatigue in MS patients.
Hypothesis 4: Action observation training with 3D virtual reality has an effect on activities of daily living in MS patients.
Hypothesis 5: Action observation training with 3D virtual reality has an effect on quality of life in MS patients.
Read the detailed description
The training will involve watching 3D videos of upper limb functions in VR and then repeating the functions by the participants. The AOT group will watch video sequences involving upper limb functions, while the control group will watch landscape videos that are not likely to elicit activity in motor or ANS areas.
In our study, 3D videos of upper limb functions will be recorded with a 360° camera and will be shown to individuals through the VR system from the primary person's perspective.
- Conditions
- Multiple Sclerosis
- Being tested
- Action observation training, sham action observation training
- Keywords
- multiple sclerosis, motor learning, action observation training, virtual reality, upper extremity function
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation trainingBehavioural
6 weeks, three days a week.
sham action observation trainingBehavioural
6 weeks, three days a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | action observation and upper extremity activities Receives: Behavioral: Action observation training |
| Control Group | Sham comparator | sham action observation and upper extremity activities Receives: Behavioral: sham action observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
upper extremity function assessment
Measured: baseline and 6th week
nine hole peg test
upper extremity function assessment
Measured: baseline and 6th week
hand dynamometer
grip strength assessment
Measured: baseline and 6th week
Secondary outcomes (4)
Fatigue severity scale
fatigue assessment
Measured: baseline and 6th week
Paced Auditory Serial Addition Test
Cognitive assessment
Measured: baseline and 6th week
The Arm Function in Multiple Sclerosis Questionnaire
activities of daily living assessment
Measured: baseline and 6th week
Multiple Sclerosis Quality of Life-54
quality of life assessment
Measured: baseline and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Nov 2023
- Primary completion2 Feb 2025
- Study completion2 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Kaya Benli, Abant Izzet Baysal University
- Investigators
- Tuba Kaya Benli, MSc, Principal investigator, Abant Izzet Baysal UniversityYeşim Bakar, Prof. Dr., Study director, Izmir Bakircay UniversityŞule Aydın Türkoğlu, Assoc. Prof., Study chair, Abant Izzet Baysal UniversityEnes Tayyip Benli, MSc, Study chair, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107023
- Sponsor's protocol ID
- AIBU-FTR-TKB-001
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bunday KL, Lemon RN, Kilner JM, Davare M, Orban GA. Grasp-specific motor resonance is influenced by the visibility of the observed actor. Cortex. 2016 Nov;84:43-54. doi: 10.1016/j.cortex.2016.09.002. Epub 2016 Sep 11.
PubMed 27697663Choi JW, Kim BH, Huh S, Jo S. Observing Actions Through Immersive Virtual Reality Enhances Motor Imagery Training. IEEE Trans Neural Syst Rehabil Eng. 2020 Jul;28(7):1614-1622. doi: 10.1109/TNSRE.2020.2998123.
PubMed 32634098Rocca MA, Meani A, Fumagalli S, Pagani E, Gatti R, Martinelli-Boneschi F, Esposito F, Preziosa P, Cordani C, Comi G, Filippi M. Functional and structural plasticity following action observation training in multiple sclerosis. Mult Scler. 2019 Oct;25(11):1472-1487. doi: 10.1177/1352458518792771. Epub 2018 Aug 7.
PubMed 30084706Sollfrank T, Hart D, Goodsell R, Foster J, Tan T. 3D visualization of movements can amplify motor cortex activation during subsequent motor imagery. Front Hum Neurosci. 2015 Aug 20;9:463. doi: 10.3389/fnhum.2015.00463. eCollection 2015.
PubMed 26347642Yoshimura M, Kurumadani H, Hirata J, Osaka H, Senoo K, Date S, Ueda A, Ishii Y, Kinoshita S, Hanayama K, Sunagawa T. Virtual reality-based action observation facilitates the acquisition of body-powered prosthetic control skills. J Neuroeng Rehabil. 2020 Aug 20;17(1):113. doi: 10.1186/s12984-020-00743-w.
PubMed 32819412Yu JA, Park J. The effect of first-person perspective action observation training on upper extremity function and activity of daily living of chronic stroke patients. Brain Behav. 2022 May;12(5):e2565. doi: 10.1002/brb3.2565. Epub 2022 Apr 10.
PubMed 35398981
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Action Observation Training With 3D Virtual Reality on Upper Extremity Functions in Patients With Multiple Sclerosis With Attacks
- ClinicalTrials.gov ID
- NCT06107023
- Acronym / sponsor ID
- AIBU-FTR-TKB-001
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, motor learning, action observation training, virtual reality, upper extremity function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Mar 2025 (actual)
- First posted
- 30 Oct 2023 (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 is a chronic, autoimmune and inflammatory disease of the Central Nervous System characterized by neuronal demyelination and axonal degeneration. Upper extremity problems are present in MS patients from an early stage, affecting the performance of the individual and leading to a decrease in activity of daily living ability in proportion to the extent of the problem. Action Observation Training is currently being examined as one of the methods used for the improvement of motor disorders and has been shown in the literature to be effective on different functions in neurological diseases.
The aim of this study was to investigate the effects of action observation training with 3D virtual reality on upper extremity functions, fatigue, cognitive functions, activities of daily living and quality of life in MS patients.
Hypothesis 1: Action observation training with 3D virtual reality has an effect on upper extremity functions in MS patients.
Hypothesis 2: Action observation training with 3D virtual reality has an effect on cognitive function in MS patients.
Hypothesis 3: Action observation training with 3D virtual reality has an effect on fatigue in MS patients.
Hypothesis 4: Action observation training with 3D virtual reality has an effect on activities of daily living in MS patients.
Hypothesis 5: Action observation training with 3D virtual reality has an effect on quality of life in MS patients.
Detailed description
The training will involve watching 3D videos of upper limb functions in VR and then repeating the functions by the participants. The AOT group will watch video sequences involving upper limb functions, while the control group will watch landscape videos that are not likely to elicit activity in motor or ANS areas.
In our study, 3D videos of upper limb functions will be recorded with a 360° camera and will be shown to individuals through the VR system from the primary person's perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Action observation trainingaction observation and upper extremity activities |
| Control Group | Sham comparator | Behavioral: sham action observation trainingsham action observation and upper extremity activities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- < 2 years MS diagnosis according to McDonald criteria
- between 3.5 and 6 the EDSS
- Nine Hole Peg Test > 30s for at least one upper extremity
- no change in medication in the last 6 months
- having MS disease with ongoing attacks
Key exclusion criteria (4 listed)
- diagnosed with neurological (except MS), cardiopulmonary, metabolic or musculoskeletal disease that would prevent treatment and evaluation
- receiving botulinum toxin treatment in the last 6 months
- visual impairment uncorrected by optical devices
- inability to adapt to treatment based on 3D immersive virtual reality (e.g. with cognitive impairment, communication problems, psychological problems or vestibular system problems)
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 |
|---|---|---|
| Action observation training6 weeks, three days a week. | Behavioural | Intervention Group |
| sham action observation training6 weeks, three days a week. | Behavioural | Control Group |
Primary outcome
Box and Block Test
Time frame: baseline and 6th week
upper extremity function assessment
nine hole peg test
Time frame: baseline and 6th week
upper extremity function assessment
hand dynamometer
Time frame: baseline and 6th week
grip strength assessment
4 secondary outcomes
Fatigue severity scale
Time frame: baseline and 6th week
Paced Auditory Serial Addition Test
Time frame: baseline and 6th week
The Arm Function in Multiple Sclerosis Questionnaire
Time frame: baseline and 6th week
Multiple Sclerosis Quality of Life-54
Time frame: baseline and 6th week
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 28 Jan 2026.
- Background: PubMed 27697663Bunday KL, Lemon RN, Kilner JM, Davare M, Orban GA. Grasp-specific motor resonance is influenced by the visibility of the observed actor. Cortex. 2016 Nov;84:43-54. doi: 10.1016/j.cortex.2016.09.002. Epub 2016 Sep 11.
- Background: PubMed 32634098Choi JW, Kim BH, Huh S, Jo S. Observing Actions Through Immersive Virtual Reality Enhances Motor Imagery Training. IEEE Trans Neural Syst Rehabil Eng. 2020 Jul;28(7):1614-1622. doi: 10.1109/TNSRE.2020.2998123.
- Background: PubMed 30084706Rocca MA, Meani A, Fumagalli S, Pagani E, Gatti R, Martinelli-Boneschi F, Esposito F, Preziosa P, Cordani C, Comi G, Filippi M. Functional and structural plasticity following action observation training in multiple sclerosis. Mult Scler. 2019 Oct;25(11):1472-1487. doi: 10.1177/1352458518792771. Epub 2018 Aug 7.
- Background: PubMed 26347642Sollfrank T, Hart D, Goodsell R, Foster J, Tan T. 3D visualization of movements can amplify motor cortex activation during subsequent motor imagery. Front Hum Neurosci. 2015 Aug 20;9:463. doi: 10.3389/fnhum.2015.00463. eCollection 2015.
- Background: PubMed 32819412Yoshimura M, Kurumadani H, Hirata J, Osaka H, Senoo K, Date S, Ueda A, Ishii Y, Kinoshita S, Hanayama K, Sunagawa T. Virtual reality-based action observation facilitates the acquisition of body-powered prosthetic control skills. J Neuroeng Rehabil. 2020 Aug 20;17(1):113. doi: 10.1186/s12984-020-00743-w.
- Background: PubMed 35398981Yu JA, Park J. The effect of first-person perspective action observation training on upper extremity function and activity of daily living of chronic stroke patients. Brain Behav. 2022 May;12(5):e2565. doi: 10.1002/brb3.2565. Epub 2022 Apr 10.
- Individual participant dataSharing planned: No
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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.
Tuba Kaya Benli, MSc principal investigator
Abant Izzet Baysal University
Yeşim Bakar, Prof. Dr. study director
Izmir Bakircay University
Şule Aydın Türkoğlu, Assoc. Prof. study chair
Abant Izzet Baysal 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 Action observation training in people with Multiple Sclerosis, run by Abant Izzet Baysal 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 28 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Box and Block Test (time frame: baseline and 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107023, which also lists 6 linked publications.
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 28 Jan 2026.