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

NCT06107023 | Completed DMC

• 1 other identifier: AIBU-FTR-TKB-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; motor learning; action observation training; virtual reality; upper extremity function

Outcome Measures

Primary Outcomes (3)

• Box and Block Test

  upper extremity function assessment

  baseline and 6th week

• nine hole peg test

  upper extremity function assessment

  baseline and 6th week

• hand dynamometer

  grip strength assessment

  baseline and 6th week

Secondary Outcomes (4)

• Fatigue severity scale

  baseline and 6th week

• Paced Auditory Serial Addition Test

  baseline and 6th week

• The Arm Function in Multiple Sclerosis Questionnaire

  baseline and 6th week

• Multiple Sclerosis Quality of Life-54

  baseline and 6th week

Study Arms (2)

Intervention Group

EXPERIMENTAL

action observation and upper extremity activities

Behavioral: Action observation training

Control Group

SHAM COMPARATOR

sham action observation and upper extremity activities

Behavioral: sham action observation training

Interventions

Action observation training BEHAVIORAL

6 weeks, three days a week.

Intervention Group

sham action observation training BEHAVIORAL

6 weeks, three days a week.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Izzet Baysal University

Bolu, Center, 14030, Turkey (Türkiye)

Location

Related 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.

  PMID: 27697663 BACKGROUND

• 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.

  PMID: 32634098 BACKGROUND

• 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.

  PMID: 30084706 BACKGROUND

• 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.

  PMID: 26347642 BACKGROUND

• 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.

  PMID: 32819412 BACKGROUND

• 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.

  PMID: 35398981 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tuba Kaya Benli, MSc

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

• Yeşim Bakar, Prof. Dr.

  Izmir Bakircay University

  STUDY DIRECTOR

• Şule Aydın Türkoğlu, Assoc. Prof.

  Abant Izzet Baysal University

  STUDY CHAIR

• Enes Tayyip Benli, MSc

  Abant Izzet Baysal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturery

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 30, 2023
• Study Start: November 15, 2023
• Primary Completion: February 2, 2025
• Study Completion: March 2, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)