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Clinical Trials/NCT05420532
NCT05420532
Unknown
Not Applicable

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

Yuzuncu Yıl University1 site in 1 country15 target enrollmentJanuary 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Yuzuncu Yıl University
Enrollment
15
Locations
1
Primary Endpoint
Nine-Hole Peg Test
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2022
End Date
August 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Yuzuncu Yıl University
Responsible Party
Principal Investigator
Principal Investigator

Asiye Tuba Ozdogar

PhD

Dokuz Eylul University

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

Outcomes

Primary Outcomes

Nine-Hole Peg Test

Time Frame: Change from Baseline at 8 weeks

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.

Secondary Outcomes

  • Arm Function in Multiple Sclerosis Questionnaire(Change from Baseline at 8 weeks)
  • Jamar Hand Dynamometer(Change from Baseline at 8 weeks)
  • The User Satisfaction Evaluation Questionnaire(immediately after the session)

Study Sites (1)

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