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Designing Virtual Reality-based Software for People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exergaming
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, virtual reality, exergaming

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exergaming Group

Arm Description

A video game-based physical activity training will be applied under a physiotherapist supervision for 1 days/week for 8 weeks.

Outcomes

Primary Outcome Measures

Nine-Hole Peg Test
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

Jamar Hand Dynamometer
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Arm Function in Multiple Sclerosis Questionnaire
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.
The User Satisfaction Evaluation Questionnaire
The User Satisfaction Evaluation Questionnaire, consisting of six questions, will be used to assess the user's satisfaction with the system and exergaming.

Full Information

First Posted
June 10, 2022
Last Updated
June 10, 2022
Sponsor
Yuzuncu Yıl University
Collaborators
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05420532
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
Collaborators
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, virtual reality, exergaming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exergaming Group
Arm Type
Experimental
Arm Description
A video game-based physical activity training will be applied under a physiotherapist supervision for 1 days/week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Exergaming
Intervention Description
A video game-based physical activity training applied using a commercial game console.
Primary Outcome Measure Information:
Title
Nine-Hole Peg Test
Description
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.
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Jamar Hand Dynamometer
Description
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Time Frame
Change from Baseline at 8 weeks
Title
Arm Function in Multiple Sclerosis Questionnaire
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
The User Satisfaction Evaluation Questionnaire
Description
The User Satisfaction Evaluation Questionnaire, consisting of six questions, will be used to assess the user's satisfaction with the system and exergaming.
Time Frame
immediately after the session
Other Pre-specified Outcome Measures:
Title
Expanded Disability Status Scale
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serkan Ozakbas, MD
Phone
0232 412 4964
Email
serkan.ozakbas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asiye Tuba Ozdogar, Research Assisstant
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Ozakbas, MD
Phone
0232 412 4964
Email
serkan.ozakbas@gmail.com
First Name & Middle Initial & Last Name & Degree
Asiye Tuba Ozdogar, MSc
First Name & Middle Initial & Last Name & Degree
Turhan Kahraman, Assoc Prof, PhD
First Name & Middle Initial & Last Name & Degree
Asiye Tuba Ozdogar, PhD
First Name & Middle Initial & Last Name & Degree
Cavid Baba, MD
First Name & Middle Initial & Last Name & Degree
Ergi Kaya, MD
First Name & Middle Initial & Last Name & Degree
Mehmet Hilal Ozcanhan, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Seda Dastan, BSc
First Name & Middle Initial & Last Name & Degree
Hilal Karakaş, BSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Designing Virtual Reality-based Software for People With Multiple Sclerosis

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