Action Observation Training With 3D Virtual Reality in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107023
• Other study ID #: AIBU-FTR-TKB-001
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Abant Izzet Baysal University
• Contact: Tuba Kaya Benli, MSc
• Phone: 05386891682
• Email: tbky1995[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Action observation training
6 weeks, three days a week.
• sham action observation training
6 weeks, three days a week.

Locations

Country	Name	City	State
Turkey	Izzet Baysal University	Bolu	Center

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test	upper extremity function assessment	baseline and 6th week
Primary	nine hole peg test	upper extremity function assessment	baseline and 6th week
Primary	hand dynamometer	grip strength assessment	baseline and 6th week
Secondary	Fatigue severity scale	fatigue assessment	baseline and 6th week
Secondary	Paced Auditory Serial Addition Test	Cognitive assessment	baseline and 6th week
Secondary	The Arm Function in Multiple Sclerosis Questionnaire	activities of daily living assessment	baseline and 6th week
Secondary	Multiple Sclerosis Quality of Life-54	quality of life assessment	baseline and 6th week