- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107023
Action Observation Training With 3D Virtual Reality in Patients With Multiple Sclerosis
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Bolu, Center, Turkey (Türkiye), 14030
- Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
action observation and upper extremity activities
|
6 weeks, three days a week.
|
|
Sham Comparator: Control Group
sham action observation and upper extremity activities
|
6 weeks, three days a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
nine hole peg test
Time Frame: baseline and 6th week
|
upper extremity function assessment
|
baseline and 6th week
|
|
hand dynamometer
Time Frame: baseline and 6th week
|
grip strength assessment
|
baseline and 6th week
|
|
Box and Block Test
Time Frame: baseline and 6th week
|
upper extremity function assessment
|
baseline and 6th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue severity scale
Time Frame: baseline and 6th week
|
fatigue assessment
|
baseline and 6th week
|
|
Paced Auditory Serial Addition Test
Time Frame: baseline and 6th week
|
Cognitive assessment
|
baseline and 6th week
|
|
The Arm Function in Multiple Sclerosis Questionnaire
Time Frame: baseline and 6th week
|
activities of daily living assessment
|
baseline and 6th week
|
|
Multiple Sclerosis Quality of Life-54
Time Frame: baseline and 6th week
|
quality of life assessment
|
baseline and 6th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tuba Kaya Benli, MSc, Abant Izzet Baysal University
- Study Director: Yeşim Bakar, Prof. Dr., Izmir Bakircay University
- Study Chair: Şule Aydın Türkoğlu, Assoc. Prof., Abant Izzet Baysal University
- Study Chair: Enes Tayyip Benli, MSc, Abant Izzet Baysal University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-TKB-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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