Clinical trial NCT05420532: Designing Virtual Reality-based Software for People With Multiple Sclerosis
Official title: Designing Virtual Reality-based Testing and Rehabilitation for Upper Extremity Software for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
virtual reality
exergaming
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
First posted: 2022-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Jamar Hand Dynamometer
timeFrame: Change from Baseline at 8 weeks
measure: Arm Function in Multiple Sclerosis Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: The User Satisfaction Evaluation Questionnaire
timeFrame: immediately after the session
Other outcomes:
measure: Expanded Disability Status Scale
timeFrame: At baseline
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References: