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Designing Virtual Reality-based Software for People With Multiple Sclerosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05420532
Enrollment
15
Registered
2022-06-15
Start date
2022-01-30
Completion date
2023-08-30
Last updated
2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, virtual reality, exergaming

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.

Interventions

OTHERExergaming

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

Sponsors

Dokuz Eylul University
CollaboratorOTHER
Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nine-Hole Peg TestChange from Baseline at 8 weeksThe 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.

Secondary

MeasureTime frameDescription
Jamar Hand DynamometerChange from Baseline at 8 weeksThe Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Arm Function in Multiple Sclerosis QuestionnaireChange from Baseline at 8 weeksArm 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.
The User Satisfaction Evaluation Questionnaireimmediately after the sessionThe User Satisfaction Evaluation Questionnaire, consisting of six questions, will be used to assess the user's satisfaction with the system and exergaming.

Other

MeasureTime frameDescription
Expanded Disability Status ScaleAt baselineThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSerkan Ozakbas, MD
serkan.ozakbas@gmail.com0232 412 4964
Backup ContactAsiye Tuba Ozdogar, Research Assisstant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026