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临床试验/NCT05420532
NCT05420532Unknown不适用

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

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Nine-Hole Peg Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Exergaming Group

Experimental

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

干预措施: Exergaming (Other)

结局指标

主要结局

Nine-Hole Peg Test

时间窗: 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.

次要结局

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

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asiye Tuba Ozdogar

PhD

Dokuz Eylul University

研究点 (1)

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