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临床试验/NCT05326711
NCT05326711已完成不适用

Effects of Telerehabilitation-Based Motor Imagery Training on Pain in People With Multiple Sclerosis

Dokuz Eylul University3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
3
主要终点
Change in Visual Analog Scale (VAS) Score

研究概览

简要总结

In this studly, the effects of an 8-week telerehabilitation-based motor imagery training on pain and related factors in persons with multiple sclerosis will be investigated.

详细描述

Multiple sclerosis (MS) is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, depression, decreased quality of life, bladder and bowel dysfunction and pain. People with Multiple Sclerosis (pwMS) show a wide range of pain symptoms, from acute pain symptoms to chronic pain symptoms. Pain is an important symptom in pwMS and is often associated with disability. Pain is a fairly common symptom in pwMS. The prevalence of pain in MS was found to be 63%. In addition, 30% of pwMS describe pain as their most severe symptom.

In the studies, it was found that motor imagery training, which is defined as imagining movement without revealing the movement in reality, is a training at the cortical level and reduces pain by creating positive effects on the impaired body schema perception. However, the effect of motor imagery training on pain in pwMS has not been investigated before.

For this reason, the aim of this study is to investigate the effect of telerehabilitation-based motor imagery training protocol, guidance of a physiotherapist, on pain, fatigue, anxiety, depression, quality of life and sleep quality in pwMS.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 32 participants will randomly be divided into 2 groups. (1) Telerehabilitation-based motor imagery training, (2) Control group. Telerehabilitation-based motor imagery training group will individually receive telerehabilitation-based motor imagery training under the guidance of a physiotherapist for 8 weeks.

The first 2 weeks of the treatment period, will reserved for implicit motor imagery / lateralization training. It will be performed by the "noi group application" application that can be downloaded to the participants' mobile devices (smartphone or tablet). Lateralization training will be aimed at the initially evaluated areas of the participants (neck, back, shoulder, knee, hand/wrist, foot/ankle) that have a pain level of at least 30 mm according to the Visual Pain Scale (VAS). In the application, the participants will be asked to discriminant right and left with simple photographs of the painful areas determined at the beginning, and more complex photographs will be used as the training progresses. Participants will be asked to use the app 3 times a day. In each application session, the right / left discrimination of the region in the photograph will be requested within 5 seconds and 30 photographs will be shown for each painful region. Each session will last 2-3 minutes on average, depending on the number of painful areas of the participants. Controls will be made over the results sent to the e-mail address of the physiotherapist through the application. For 3rd to 8th weeks of the treatment period telehabilitation-based motor imagery training will be given to the participants individually, in synchronization, using the Google Meet videoconference platform, under the guidance of a physiotherapist. Participants will participate the treatment with their smart phones, tablets or computers that have an active internet connection and are suitable for meeting via videoconference. The duration of the sessions will last 20-30 minutes.

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

  • Having been diagnosed with MS according to McDonald diagnostic criteria
  • Not having an attack in the last 3 months.
  • To have sufficient smartphone/tablet or computer knowledge to participate in the study or to have a relative who can help in this regard.
  • Having an active internet connection at home.
  • Having a smart phone/tablet or computer suitable for videoconferencing.
  • Having a smartphone or tablet.
  • Having a pain level of at least 30 mm on the 100 mm visual analog scale (VAS) for at least 3 months in at least one of the hand/wrist, foot/ankle, knee, shoulder, neck and back regions.
  • No change in medications used for pain in the last 2 months.
  • Not receiving additional treatment other than routine treatments.
  • To be able to read and understand Turkish.

排除标准

  • Pregnancy
  • Having a musculoskeletal, cardiovascular, pulmonary, metabolic, or other disease severe enough to preclude participation in the study.
  • Presence of conditions other than MS that can cause pain, such as cancer, diabetes, overt osteoarthritis, or rheumatoid arthritis based on laboratory or imaging findings
  • Having a psychiatric illness.
  • Presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed
  • Having severe vision and hearing problems.

结局指标

主要结局

Change in Visual Analog Scale (VAS) Score

时间窗: The assessments will be applied at baseline, 8, and 12 weeks.

VAS will be used to numerically determine the general pain intensities felt by participants in the last 2 days and the pain intensities of the areas they feel painful on six regions: neck, shoulder, back, hand/wrist, knee, foot/ankle. Participants will be told that 0mm above the 100mm line had "no pain"; It will be stated that 100 mm represents "the most unbearable pain". The degree of pain will be recorded numerically between 0 and 100.

次要结局

  • Expanded Disability Status Scale(The assessment will be applied at baseline.)
  • Change in Numeric Rating Scale Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Kinesthetic and Visual Imagery Questionnaire- 20 Score(The assessments will be applied at baseline, 8, and 12 weeks.)
  • Change in Patient-Determined Disease Steps Scale Score(The assessments will be applied at baseline and 8 weeks.)
  • Change in Epworth Sleepiness Scale Score(The assessments will be applied at baseline, 8, and 12 weeks.)
  • Change in PainDETECT Questionnaire Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Modified Fatigue Impact Scale Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Hospital Anxiety and Depression Scale (HADS) Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Mental Chronometer Time Ratio for Timed Up and Go Test Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Nordic Musculoskeletal Questionnaire Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Pittsburgh Sleep Quality Index Score(The assessments will be applied at baseline, 8, and 12 weeks.)
  • Change in California Verbal Learning Test-II Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Multiple Sclerosis İnternational Quality of Life Questionnaire Score(The assessments will be applied at baseline, 8, and 12 weeks.)
  • Change in Symbol Digit Modalities Test Test Score(The assessments will be applied at baseline, 8, and 12 weeks)
  • Change in Revised Brief Visuospatial Memory Test Score(The assessments will be applied at baseline, 8, and 12 weeks)

研究者

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

Turhan Kahraman

Assoc Prof

Dokuz Eylul University

研究点 (3)

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