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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06107023
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Abant Izzet Baysal University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tuba Kaya Benli, MScYeşim Bakar, Prof. Dr.Şule Aydın Türkoğlu, Assoc. Prof.Enes Tayyip Benli, MSc
Principal Investigator Affiliation Abant Izzet Baysal UniversityIzmir Bakircay UniversityAbant Izzet Baysal UniversityAbant Izzet Baysal University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Intervention Group

action observation and upper extremity activities

Sham Comparator: Control Group

sham action observation and upper extremity activities

Interventions

Behavioral: - Action observation training

6 weeks, three days a week.

Behavioral: - sham action observation training

6 weeks, three days a week.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Izzet Baysal University, Bolu, Center, Turkey

Status

Recruiting

Address

Izzet Baysal University

Bolu, Center, 14030

Site Contact

Tuba Kaya Benli, MSc

[email protected]

05386891682

Nearest Location

Site Contact

Tuba Kaya Benli, MSc

[email protected]

05386891682


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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