Clinical trial NCT06107023: Action Observation Training With 3D Virtual Reality in Patients With Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
motor learning
action observation training
virtual reality
upper extremity function
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* \< 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Action Research Arm Test
timeFrame: baseline and 6th week
measure: nine hole peg test
timeFrame: baseline and 6th week
measure: hand dynamometer
timeFrame: baseline and 6th week
Secondary outcomes:
measure: Fatigue severity scale
timeFrame: baseline and 6th week
measure: Paced Auditory Serial Addition Test
timeFrame: baseline and 6th week
measure: The Arm Function in Multiple Sclerosis Questionnaire
timeFrame: baseline and 6th week
measure: Multiple Sclerosis Quality of Life-54
timeFrame: baseline and 6th week
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Izzet Baysal University
state: Center
Study officials:
affiliation: Abant Izzet Baysal University
name: Tuba Kaya Benli, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Bakircay University
name: Yeşim Bakar, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Abant Izzet Baysal University
name: Şule Aydın Türkoğlu, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Abant Izzet Baysal University
name: Enes Tayyip Benli, MSc
role: STUDY_CHAIR
References:
citation: 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.
citation: Choi 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.
citation: Rocca 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.
citation: Sollfrank 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.
citation: Yoshimura 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.
citation: Yu 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.