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

NCT ID: NCT06107023

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-03-02

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

action observation and upper extremity activities

Group Type EXPERIMENTAL

Action observation training

Intervention Type BEHAVIORAL

6 weeks, three days a week.

Control Group

sham action observation and upper extremity activities

Group Type SHAM_COMPARATOR

sham action observation training

Intervention Type BEHAVIORAL

6 weeks, three days a week.

Interventions

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Action observation training

6 weeks, three days a week.

Intervention Type BEHAVIORAL

sham action observation training

6 weeks, three days a week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Tuba Kaya Benli

lecturery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuba Kaya Benli, MSc

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Yeşim Bakar, Prof. Dr.

Role: STUDY_DIRECTOR

Izmir Bakircay University

Şule Aydın Türkoğlu, Assoc. Prof.

Role: STUDY_CHAIR

Abant Izzet Baysal University

Enes Tayyip Benli, MSc

Role: STUDY_CHAIR

Abant Izzet Baysal University

Locations

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Izzet Baysal University

Bolu, Center, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27697663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32634098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30084706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26347642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32819412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35398981 (View on PubMed)

Other Identifiers

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AIBU-FTR-TKB-001

Identifier Type: -

Identifier Source: org_study_id

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