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Completed

NCT Number: NCT06107023

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izzet Baysal University

Bolu, Center, 14030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Action observation training

Behavioral

6 weeks, three days a week.

sham action observation training

Behavioral

6 weeks, three days a week.

Primary outcomes

  1. Box and Block Test

    Time frame: baseline and 6th week

    upper extremity function assessment

  2. nine hole peg test

    Time frame: baseline and 6th week

    upper extremity function assessment

  3. hand dynamometer

    Time frame: baseline and 6th week

    grip strength assessment

Secondary outcomes

  1. Fatigue severity scale

    Time frame: baseline and 6th week

    fatigue assessment

  2. Paced Auditory Serial Addition Test

    Time frame: baseline and 6th week

    Cognitive assessment

  3. The Arm Function in Multiple Sclerosis Questionnaire

    Time frame: baseline and 6th week

    activities of daily living assessment

  4. Multiple Sclerosis Quality of Life-54

    Time frame: baseline and 6th week

    quality of life assessment

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Investigation of the Effect of Action Observation Training With 3D Virtual Reality on Upper Extremity Functions in Patients With Multiple Sclerosis With Attacks

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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