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临床试验/NCT07710742
NCT07710742尚未招募不适用

Investigation of the Effects of Motor Imagery and Sensorimotor Training on Neuropathic Pain, Proprioception, Balance, and Reaction Time in Multiple Sclerosis

Uludag University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
Assessment of Neuropathic Pain

研究概览

简要总结

Many types of pain can occur in Multiple Sclerosis (MS), one of the most common types is neuropathic pain. Neuropathic pain is directly related to the disease's demyelination process and is associated with dysesthetic pain, allodynia, hyperalgesia. For neuropathic pain in MS, there are numerous physical therapy and rehabilitation interventions focused on proprioception, balance reaction time management. Loss of proprioception is commonly observed in MS, this loss results from the demyelination of the central somatosensory pathways. Proprioception-the ability to perceive the position of the body and limbs relative to the environment-is also related to balance performance. Balance problems can be detected in the early stages of the disease, even if the patient has no disability. Another effect of MS is observed in reaction time. In MS, which is characterized by demyelination, axonal damage, a slowing of nerve conduction velocity leads to a decrease in information processing speed, resulting in prolonged reaction times. Neuromuscular training models designed to train the Central Nervous System (CNS) can be used to address these effects.Motor Imagery (MI) is one of the neuromuscular training models.

Imagery can be defined as the use of all one's senses to create a mental image of an activity. MI is referred to as a brain-training method and utilizes the neuromatrix theory to inhibit pain. MI training aims to retrain the neural networks that activate the neuromatrix so that they become less sensitive to stimuli that would not normally cause pain. Lateralization is a method used in conjunction with MI to distinguish between the right and left sides of the painful area. The imagery phase involves visualizing the positions and movements of the painful areas. MI is a neuromuscular training model, and another neuromuscular training method is Sensorimotor (SM) training.

It is known that SM, which applies repetitive sensorimotor stimulation, passively improves sensorimotor performance. Known as perceptual learning, this approach involves simple exposure to SM stimulation for several hours. While the term "perceptual" encompasses various senses, including sight and hearing, the term "sensorimotor training" is used here specifically to refer to methods focused on SM stimulation. SM training typically does not require participants to actively focus on external stimuli, which makes it easily applicable in neuro-rehabilitation settings. It does not focus solely on increasing muscle strength in a specific area; rather, it aims to improve movement quality and patterns by training the CNS. This training model, which emphasizes the importance of sensory input in developing motor skills, plays an effective role in improving balance, enhancing functionality, and reducing pain. Studies demonstrating the effectiveness of SM interventions in MS are available. The literature shows that both MI and SM have effects on neuropathic pain, proprioception, balance, and reaction time in individuals with MS. These two methods involve different neurophysiological mechanisms. For example, MI sends a "top-down" message to the brain. It first uses laterality (right/left distinction), then imagery, and prepares the brain for movement. SM, however, sends a "bottom-up" message to the brain. It focuses primarily on sensory input. Furthermore, while MI is an approach that aims to activate central motor networks without peripheral afferent input, SM supports central motor control processes by enhancing peripheral sensory input. In addition to these differences, it is known that both methods actually train CNS.The literature shows that both MI and SM have effects on neuropathic pain, proprioception, balance, and reaction time in individuals with MS. These two methods involve different neurophysiological mechanisms. For example, MI sends a "top-down" message to the brain. It first uses laterality (right/left distinction), then imagery, and prepares the brain for movement. SM, however, sends a "bottom-up" message to the brain. It focuses primarily on sensory input. Furthermore, while MI is an approach that aims to activate central motor networks without peripheral afferent input, SM supports central motor control processes by enhancing peripheral sensory input. There are only a few studies comparing these two methods.No studies have been found in the literature that compare these two methods in patients with MS and examine their effects.

The aim of our study is to examine the effects of MI and SM training administered to individuals with MS. Motor control in patients with MS is a process resulting from the interaction of central and peripheral mechanisms. For this reason, it is believed that comparing the relative effects of central-focused (MI) and peripheral-focused (SM) approaches could contribute to the development of rehabilitation interventions.

详细描述

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, progressive neurological disease that affects the Central Nervous System (CNS). Among the most common problems in MS are neuropathic pain, loss of proprioception, and balance issues. Many types of pain can be observed in MS, and neuropathic pain is one of the most common types. Neuropathic pain is directly related to the disease's demyelination process and is associated with dysesthetic pain, allodynia, and hyperalgesia. For neuropathic pain in MS, there are numerous physical therapy and rehabilitation interventions focused on proprioception, balance, and reaction time management. Loss of proprioception is commonly observed in MS, and this loss results from the demyelination of the central somatosensory pathways. Loss of proprioception negatively affects the patient's independence in activities of daily living. Proprioception-the ability to perceive the position of the body and limbs relative to the environment-is also related to balance performance. Balance problems are observed in 50-80% of people with MS. Balance problems emerge throughout the course of MS and, while they may worsen with recurrent relapses, they can also occur between relapses. Balance problems can be detected in the early stages of the disease, even in the absence of any disability. Another effect of MS is observed in reaction time. In MS, which is characterized in particular by demyelination and axonal damage, a slowing of nerve conduction velocity leads to a decrease in information processing speed, resulting in prolonged reaction time. Studies have shown that reaction time is significantly longer in people with MS compared to healthy individuals. Neuromuscular training models designed to train the CNS can be used to treat these conditions. Motor Imagery (MI) is one such neuromuscular training model.

Imagery can be defined as the use of all the senses to create a mental image of an activity. MI is referred to as a brain training method and utilizes the neuromatrix theory to inhibit pain. MI training aims to retrain the neural networks that activate the neuromatrix so that they become less sensitive to stimuli that would not normally cause pain. Lateralization is a method used in conjunction with MI to distinguish between the right and left sides of the painful area. The imagery phase is defined as visualizing the positions and movements of the painful areas. A study examining the effects of telerehabilitation-based MI training on pain and related factors in individuals with MS included 32 participants with MS. Two groups were formed-a treatment group and a control group-and the treatment group received MI training via telerehabilitation for 8 weeks. The outcome measures included pain, motor imagery ability, cognitive functions, fatigue, quality of life, sleep quality, daytime sleepiness, and levels of depression and anxiety. The results of the study showed a significant reduction in the treatment group in overall pain intensity over the last two and seven days, in pain intensity in areas other than the elbow region over the last seven days, and in fatigue and depression levels, while there was an increase in MI ability, quality of life, and scores for processing speed and visual memory in cognitive functions. Another study examined the physical, cognitive, and psychosocial effects of telerehabilitation-based MI training in individuals with MS. A group of MS patients and a healthy control group were formed, and the MS patients underwent 8 weeks of MI training. The results of the study showed significant improvements in the intervention group in dynamic balance during walking, walking speed, perceived walking ability, balance confidence, most cognitive functions, fatigue, anxiety, depression, and quality of life. When these two studies are examined, it is possible to conclude that MI has a positive effect on individuals with MS across multiple parameters. MI is a neuromuscular training model, and another neuromuscular training method is Sensorimotor (SM) training.It is known that SM, which applies repetitive sensorimotor stimulation, passively enhances sensorimotor performance. Known as perceptual learning, this approach involves simple exposure to SM stimulation for several hours. While the term "perceptual" encompasses various senses, including sight and hearing, the term "sensorimotor training" is used here specifically to refer to methods focused on SM stimulation. SM training typically does not require participants to actively focus on external stimuli, making it easily applicable in neuro-rehabilitation settings. It does not focus solely on increasing muscle strength in a specific region but aims to improve movement quality and patterns by training CNS. This training model, which emphasizes the importance of sensation in developing motor skills, plays an effective role in improving balance, enhancing functionality, and reducing pain. Studies demonstrating the effectiveness of SM interventions in MS are available. A randomized controlled trial conducted with MS patients, a robot-assisted intervention and an SM training intervention were applied to improve upper extremity motor function. Forty-two MS patients were divided into two groups and received treatment twice a week for four weeks. The study found that the SM intervention was effective in improving upper extremity motor function. In another study, the effects of SM balance training on balance disorders, perceived balance confidence, quality of life, fatigue, fall frequency, and sensory integration processing were compared with those of traditional rehabilitation in 80 patients with MS. Patients were assessed by a blind evaluator before treatment, after treatment, and one month after treatment using the Berg Balance Scale (BBS), the Activity-Specific Balance Confidence Scale (ABC), the Multiple Sclerosis Quality of Life-54, the Fatigue Severity Scale (FSS), the number of falls, and the Sensory Organization Test (SOT). The study found that SM is effective in improving balance disorders in patients with MS. The literature shows that both MI and SM have effects on neuropathic pain, proprioception, balance, and reaction time in individuals with MS. These two methods involve different neurophysiological mechanisms. For example, MI sends a "top-down" message to the brain. It first uses laterality (right/left distinction), then imagery, and prepares the brain for movement. SM, however, sends a "bottom-up" message to the brain. It focuses primarily on sensory input. Furthermore, while MI is an approach that aims to activate central motor networks without peripheral afferent input, SM supports central motor control processes by enhancing peripheral sensory input.There are only a few studies comparing these two methods. In a study conducted on individuals with knee osteoarthritis, three groups were identified: one group received SM, one group received MI, and the other group received conventional treatment. As a result of the intervention, which was administered twice a week for a total of 6 weeks, it was concluded that MI and SM exercises significantly improved static and dynamic balance, thereby reducing the risk of falls, and-particularly during early rehabilitation-promoted proprioceptive development at small angles (20°). No studies have been found in the literature that compare these two methods in patients with MS and examine their effects.

The aim of our study is to examine the effects of MI and SM training in individuals with MS. Motor control in patients with MS is a process resulting from the interaction of central and peripheral mechanisms. For this reason, it is believed that comparing the relative effects of central-focused (MI) and peripheral-focused (SM) approaches could contribute to the development of rehabilitation interventions.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-45 years of age,
  • Having received a definitive MS diagnosis according to the 2024 McDonald criteria,
  • Not having had a relapse in the past 3 months,
  • Having an EDSS score of ≤ 6.00,
  • Presence of neuropathic pain in the lower extremities that has persisted for at least 3 months or is recurrent,
  • Confirmation of the presence of neuropathic pain by a neurologist,

排除标准

  • The presence of any other orthopedic or neurological condition that could interfere with participation in the study,
  • A level of spasticity in the lower extremities of ≥ 1+ on the Modified Ashworth Scale,
  • The presence of any hearing, vision, or cognitive impairment that could interfere with the assessments,
  • Receiving additional treatment beyond routine medication,
  • Participating in another physical therapy program during the study period,
  • Having conditions unrelated to MS that cause pain.

结局指标

主要结局

Assessment of Neuropathic Pain

时间窗: Registration to the end of the 12th week

Algometer will be used. Each patient will be taught how to distinguish between tactile and painful stimuli. PPT will be recorded as the amount of pressure required to elicit a sensation of pain distinct from pressure or discomfort. Patients will be asked to say "stop" as soon as they feel a distinct sensation of pain; at that point, the algometer's pressure will be released immediately and the piston will be retracted by the evaluator.

Assessment of Neuropathic Pain

时间窗: From the registration stage until the end of the 12th week

The Leeds Neuropathic Symptoms and Signs Assessment (S-LANSS) will be used. The S-LANSS consists of a 5-item questionnaire regarding pain symptoms and a 2-item clinical symptom scale that includes self-administered sensory tests for the presence of allodynia and reduced sensitivity to needle pricks. Responses to each item are binary (yes or no), and each item is weighted differently based on the odds ratio of a positive response to that item, in order to predict whether the pain is primarily neuropathic. Possible scores range from 0 to 24, and a score of 12 or higher suggests neuropathic pain.

Reaction Time Assesments

时间窗: From the registration stage until the end of the 12th week.

Kinovea software will be used. The feature that allows the video to continue without disrupting the flow of time while slowing it down will be utilized. A video recording capturing the reaction to taking a step will be made and uploaded to the Kinovea software.

Balance Assessment

时间窗: From the registration stage until the end of the 12th week.

HUR SmartBalance BTG4 balance platform will be used.Postural stability and stability limits will be measured and recorded.

Joint Position Sense

时间窗: From the registration stage until the end of the 12th week.

Digital Goniometer will be used. For the lower extremity, the following angles will be measured and recorded: 60 degrees of hip flexion; 45 degrees of knee flexion; and 15 degrees of ankle dorsiflexion.

次要结局

  • Motor Imagery Ability Assessment(From the registration stage until the end of the 12th week)
  • Anxiety and Depression Assesments(From the registration stage until the end of the 12th week)
  • Mental Chronometer(From registration up to the 12th week)
  • Cognitive Functions Assessment(From the registration stage until the end of the 12th week)
  • Fatigue Assessment(From the registration stage until the end of the 12th week)
  • MS Symptom Severity Assessment(From the registration stage until the end of the 12th week)
  • Walk Assesments(From the registration stage until the end of the 12th week)
  • Backward Walking Assesments(From the registration stage until the end of the 12th week)

研究者

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

Şeyma Dilek

Research Assistant

Uludag University

研究点 (1)

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