Designing Virtual Reality-based Software for People With Multiple Sclerosis

June 10, 2022 updated by: Asiye Tuba Ozdogar, Yuzuncu Yıl University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Asiye Tuba Ozdogar, Research Assisstant

Study Locations

  • Turkey
      • İzmir, Turkey
        • Recruiting
        • Dokuz Eylul University
        • Contact:
        • Sub-Investigator:
          • Cavid Baba, MD
        • Sub-Investigator:
          • Seda Dastan, BSc
        • Sub-Investigator:
          • Hilal Karakaş, BSc
        • Contact:
          • Asiye Tuba Ozdogar, MSc
        • Sub-Investigator:
          • Turhan Kahraman, Assoc Prof, PhD
        • Principal Investigator:
          • Asiye Tuba Ozdogar, PhD
        • Sub-Investigator:
          • Ergi Kaya, MD
        • Sub-Investigator:
          • Mehmet Hilal Ozcanhan, Assoc. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergaming Group
A video game-based physical activity training will be applied under a physiotherapist supervision for 1 days/week for 8 weeks.
Other: Exergaming
A video game-based physical activity training applied using a commercial game console.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jamar Hand Dynamometer
Time Frame: Change from Baseline at 8 weeks
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Change from Baseline at 8 weeks
Arm Function in Multiple Sclerosis Questionnaire
Time Frame: Change from Baseline at 8 weeks
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
The User Satisfaction Evaluation Questionnaire
Time Frame: immediately after the session
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expanded Disability Status Scale
Time Frame: At baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Collaborators

Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Anticipated)

July 15, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/14-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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