Designing Virtual Reality-based Software for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Designing Virtual Reality-based Testing and Rehabilitation for Upper Extremity Software for People With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420532
• Other study ID #: 2022/14-02
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: June 2022
• Source: Yuzuncu Yil University
• Contact: Serkan Ozakbas, MD
• Phone: 0232 412 4964
• Email: serkan.ozakbas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 30, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Exergaming
A video game-based physical activity training applied using a commercial game console.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Yuzuncu Yil University	Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expanded Disability Status Scale	The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.	At baseline
Primary	Nine-Hole Peg Test	The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.	Change from Baseline at 8 weeks
Secondary	Jamar Hand Dynamometer	The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.	Change from Baseline at 8 weeks
Secondary	Arm Function in Multiple Sclerosis Questionnaire	Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.	Change from Baseline at 8 weeks
Secondary	The User Satisfaction Evaluation Questionnaire	The User Satisfaction Evaluation Questionnaire, consisting of six questions, will be used to assess the user's satisfaction with the system and exergaming.	immediately after the session