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

Sponsor

Abant Izzet Baysal University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06107023

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Action observation training Behavioral: sham action observation training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group action observation and upper extremity activities	Behavioral: Action observation training 6 weeks, three days a week.
Sham Comparator: Control Group sham action observation and upper extremity activities	Behavioral: sham action observation training 6 weeks, three days a week.

Arm

Intervention/Treatment

Experimental: Intervention Group

action observation and upper extremity activities

Behavioral: Action observation training

6 weeks, three days a week.

Sham Comparator: Control Group

sham action observation and upper extremity activities

Behavioral: sham action observation training

6 weeks, three days a week.

Outcome Measures

Primary Outcome Measures

Action Research Arm Test [baseline and 6th week]
upper extremity function assessment
nine hole peg test [baseline and 6th week]
upper extremity function assessment
hand dynamometer [baseline and 6th week]
grip strength assessment

Secondary Outcome Measures

Fatigue severity scale [baseline and 6th week]
fatigue assessment
Paced Auditory Serial Addition Test [baseline and 6th week]
Cognitive assessment
The Arm Function in Multiple Sclerosis Questionnaire [baseline and 6th week]
activities of daily living assessment
Multiple Sclerosis Quality of Life-54 [baseline and 6th week]
quality of life assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)