Designing Virtual Reality-based Software for People With Multiple Sclerosis

NCT ID: NCT05420532

Last Updated: 2022-06-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2023-08-30

Brief Summary

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The study aims to designing virtual reality-based testing and rehabilitation software for people with multiple sclerosis and assess the feasibility of software. Also, the effects of an 8-week virtual reality-based upper extremity training in persons with multiple sclerosis will be investigated.

Detailed Description

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Multiple sclerosis (MS) is a chronic, inflammatory, and demyelinating disorder that requires long-term rehabilitation. Numerous systematic reviews on MS have demonstrated the effectiveness of rehabilitation strategies such as exercise training, physical therapy, occupational therapy, and multidisciplinary therapy. However, despite the importance of upper extremity performance in daily functional activities, rehabilitation of people with MS (pwMS) generally focuses more on gait and balance, and upper extremity problems remain in the background.

In addition, rehabilitation treatments for pwMS are described as very long and systematic, leading to loss of motivation and adjustment. As a result, technology-based rehabilitation systems such as virtual reality (VR) have been promising in recent years and can provide person-centered task-oriented rehabilitation without needing a device or controller.

In pwMS, physiotherapy and rehabilitation programs based on today's VR studies are usually prepared with game software for computer users without physical disabilities. However, the number of these studies based solely on classical game software has a limited place in treating patients today and is considered insufficient. Moreover, this software is complicated for patients, has a fast-paced structure, and fails to provide disability-focused education or meet patient needs.

For this reason, it is necessary to develop specific game software for pwMS. The study aims to develop virtual reality exergame software for upper extremity rehabilitation in pwMS and evaluate the usability.

Persons who are followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. Fifteen participants will be included to determine the feasibility of the software, and they will experience the system for one session. Then 15 participants will be included to investigate the effects of software on upper extremity functions during 8 weeks.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exergaming Group

A video game-based physical activity training will be applied under a physiotherapist supervision for 1 days/week for 8 weeks.

Group Type EXPERIMENTAL

Exergaming

Intervention Type OTHER

A video game-based physical activity training applied using a commercial game console.

Interventions

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Exergaming

A video game-based physical activity training applied using a commercial game console.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having a definitive diagnosis of MS according to the 2017 McDonald criteria
* Being over 18 years old
* To be willing to participate in the study.

Exclusion Criteria

* Having a neurological disease other than MS
* Cognitive disability at a level that hinders assessment and treatment.
* Having a relapse 30 days before or during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role collaborator

Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Asiye Tuba Ozdogar

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serkan Ozakbas, MD

Role: CONTACT

0232 412 4964

Asiye Tuba Ozdogar, Research Assisstant

Role: CONTACT

Facility Contacts

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Serkan Ozakbas, MD

Role: primary

0232 412 4964

Asiye Tuba Ozdogar, MSc

Role: backup

Other Identifiers

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2022/14-02

Identifier Type: -

Identifier Source: org_study_id

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