CClinicalTrials.gg
Status unknownNCT05420532Updated Jun 15, 2022

Designing Virtual Reality-based Software for People With Multiple Sclerosis

An interventional study of Exergaming in Multiple Sclerosis, sponsored by Yuzuncu Yıl University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2022, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • multiple sclerosis
  • virtual reality
  • exergaming
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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

Interventions

  • OtherExergaming

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline at 8 weeks

Secondary outcomes

  1. Jamar Hand Dynamometer

    The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.

    Time frame: Change from Baseline at 8 weeks

  2. 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.

    Time frame: Change from Baseline at 8 weeks

  3. 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.

    Time frame: immediately after the session

Other outcomes

  1. Expanded Disability Status Scale

    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

07

Study locations

1 of 1 sites recruiting
  • Dokuz Eylul University
    İzmir, Turkey
    • Serkan Ozakbas, MD · Contact · serkan.ozakbas@gmail.com · 0232 412 4964
    • Asiye Tuba Ozdogar, MSc · Contact
    • Turhan Kahraman, Assoc Prof, PhD · Sub investigator
    • Asiye Tuba Ozdogar, PhD · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05420532
Lead sponsor
Yuzuncu Yıl University
Collaborators
Dokuz Eylul University
Responsible party
Asiye Tuba Ozdogar (PhD, Dokuz Eylul University) — Principal investigator
First posted
Jun 15, 2022
Start date
Jan 30, 2022
Primary completion
Jul 15, 2023 (estimated)
Completion
Aug 30, 2023 (estimated)
Last update
Jun 15, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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