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临床试验/NCT06107023
NCT06107023已完成不适用

Investigation of the Effect of Action Observation Training With 3D Virtual Reality on Upper Extremity Functions in Patients With Multiple Sclerosis With Attacks

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
nine hole peg test

研究概览

简要总结

Multiple sclerosis is a chronic, autoimmune and inflammatory disease of the Central Nervous System characterized by neuronal demyelination and axonal degeneration. Upper extremity problems are present in MS patients from an early stage, affecting the performance of the individual and leading to a decrease in activity of daily living ability in proportion to the extent of the problem. Action Observation Training is currently being examined as one of the methods used for the improvement of motor disorders and has been shown in the literature to be effective on different functions in neurological diseases.

The aim of this study was to investigate the effects of action observation training with 3D virtual reality on upper extremity functions, fatigue, cognitive functions, activities of daily living and quality of life in MS patients.

Hypothesis 1: Action observation training with 3D virtual reality has an effect on upper extremity functions in MS patients.

Hypothesis 2: Action observation training with 3D virtual reality has an effect on cognitive function in MS patients.

Hypothesis 3: Action observation training with 3D virtual reality has an effect on fatigue in MS patients.

Hypothesis 4: Action observation training with 3D virtual reality has an effect on activities of daily living in MS patients.

Hypothesis 5: Action observation training with 3D virtual reality has an effect on quality of life in MS patients.

详细描述

The training will involve watching 3D videos of upper limb functions in VR and then repeating the functions by the participants. The AOT group will watch video sequences involving upper limb functions, while the control group will watch landscape videos that are not likely to elicit activity in motor or ANS areas.

In our study, 3D videos of upper limb functions will be recorded with a 360° camera and will be shown to individuals through the VR system from the primary person's perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

入选标准

  • < 2 years MS diagnosis according to McDonald criteria
  • between 3.5 and 6 the EDSS
  • Nine Hole Peg Test > 30s for at least one upper extremity
  • no change in medication in the last 6 months
  • having MS disease with ongoing attacks
  • >2 Modified Ashworth Scale in the upper extremities

排除标准

  • diagnosed with neurological (except MS), cardiopulmonary, metabolic or musculoskeletal disease that would prevent treatment and evaluation
  • receiving botulinum toxin treatment in the last 6 months
  • visual impairment uncorrected by optical devices
  • inability to adapt to treatment based on 3D immersive virtual reality (e.g. with cognitive impairment, communication problems, psychological problems or vestibular system problems)

研究组 & 干预措施

Intervention Group

Experimental

action observation and upper extremity activities

干预措施: Action observation training (Behavioral)

Control Group

Sham Comparator

sham action observation and upper extremity activities

干预措施: sham action observation training (Behavioral)

结局指标

主要结局

nine hole peg test

时间窗: baseline and 6th week

upper extremity function assessment

Box and Block Test

时间窗: baseline and 6th week

upper extremity function assessment

hand dynamometer

时间窗: baseline and 6th week

grip strength assessment

次要结局

  • Fatigue severity scale(baseline and 6th week)
  • Paced Auditory Serial Addition Test(baseline and 6th week)
  • The Arm Function in Multiple Sclerosis Questionnaire(baseline and 6th week)
  • Multiple Sclerosis Quality of Life-54(baseline and 6th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuba Kaya Benli

lecturery

Abant Izzet Baysal University

研究点 (1)

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