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Designing Virtual Reality-based Software for People With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05420532
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
Dokuz Eylul University
Information provided by (Responsible Party):
Asiye Tuba Ozdogar, Dokuz Eylul University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Exergaming Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Designing Virtual Reality-based Testing and Rehabilitation for Upper Extremity Software for People With Multiple Sclerosis
Actual Study Start Date : January 30, 2022
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05420532


Contacts
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Contact: Serkan Ozakbas, MD 0232 412 4964 serkan.ozakbas@gmail.com
Contact: Asiye Tuba Ozdogar, Research Assisstant

Locations
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Turkey
Dokuz Eylul University Recruiting
İzmir, Turkey
Contact: Serkan Ozakbas, MD    0232 412 4964    serkan.ozakbas@gmail.com   
Contact: Asiye Tuba Ozdogar, MSc         
Sub-Investigator: Turhan Kahraman, Assoc Prof, PhD         
Principal Investigator: Asiye Tuba Ozdogar, PhD         
Sub-Investigator: Cavid Baba, MD         
Sub-Investigator: Ergi Kaya, MD         
Sub-Investigator: Mehmet Hilal Ozcanhan, Assoc. Prof.         
Sub-Investigator: Seda Dastan, BSc         
Sub-Investigator: Hilal Karakaş, BSc         
Sponsors and Collaborators
Yuzuncu Yıl University
Dokuz Eylul University
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Responsible Party: Asiye Tuba Ozdogar, PhD, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT05420532    
Other Study ID Numbers: 2022/14-02
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asiye Tuba Ozdogar, Dokuz Eylul University:
multiple sclerosis
virtual reality
exergaming
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases