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临床试验/NCT05727826
NCT05727826招募中不适用

The Investigation of the Effectiveness of Vibratory Stimulation on Upper Limb Function, Pain and Sensation in Patients With Stroke.

Yeditepe University2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2023年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Box and block test (BBT)

研究概览

简要总结

The objectives of this study cover both the vibration stimulation intervention and its outcomes. Patients with stroke frequently experience spasm in both the lower and upper extremities, which impairs sensory perception and motor function. This study aims to evaluate the effects of vibration therapy on the forearm and arm extensors of stroke patients and to report on changes in sensory perception and motor function measures. Although vibration therapy has lately been utilized to treat these limbs, there haven't been enough trials to determine how beneficial it is in the application procedure. This study aims to investigate the outcomes and effectiveness of a vibration therapy program administered to the extensor muscles.

详细描述

One of the major disadvantages is the loss of muscle strength in patients with post-stroke hemiplegia. Muscle weakness is caused after a stroke, followed by limited movement . Tactile and proprioceptive sensations are reduced in up to 65% of hemiplegic patients. Furthermore, pain, temperature, and touch are reduced. Because the ability to perceive these sensory features is impaired, recognizing objects by touch or exploring the environment can be difficult. Furthermore, it is stated that the senses are important and influence the recognition of skilled movements. A disorder has negative consequences for safety, natural hand use, the ability to maintain an appropriate level of strength while grasping without vision, and difficulties with object management. In this way, regaining motor control is a complex and time-consuming process. The increased unmasking of neural covert connections and the number of synapses in dendrites are two mechanisms by which the brain reorganizes itself. It has been observed that functionally relevant adaptive changes occur in the brain following an injury .Segmental muscle vibration (SMV) is a technique that uses a mechanical apparatus to deliver a vibratory stimulus to a specific tendon. As a result of the facilitation of muscle spindle primary ends, SMV provides Ia inputs. By managing intracortical inhibition and activating sensory inputs to the primary motor cortex, Ia sensory inputs facilitated by SMV can alter the activation of the corticospinal pathway. Transcranial magnetic simulation was used in a previous study after low-amplitude SMV was applied to the flexor carpi radialis muscle and inner hand muscles, and increased excitability in the primary motor cortex .While systematic data on improving human somatosensation are lacking, many accounts indicate that there is room for improvement. Furthermore, previous research on lesioned primates has shown that extensive training in touch, proprioception, and vibration improves even the most complex discriminating abilities. It also aided in the identification of the somatosensory cortex. As a result, the purpose of this study was to better understand the pure effect of repeated vibratory stimulation and its long-term effects two weeks after the last intervention session, when compared to the experimental or control groups.

In summary, studies in the literature have used a vibratory stimulation device to perform arm and wrist flexor motion therapy. This will be the first study to look at how vibratory stimulation of the forearm and arm extensor muscles affects upper extremity function, sensation, and pain parameters in hemiplegic patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

The sample number of the study was calculated with the program named G*Power 3.1.9.2. The sample size of the study was calculated as 10 in total, with an error of +/-0.5, an effect size of 0.44 calculated for an estimated standard deviation of 1.26, a power of 80% and a margin of error of 5%.

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Box and block test (BBT)

时间窗: 60 seconds

Box and block test (BBT) which is used to assess unilateral gross manual dexterity and functional abilities of upper extremity specifically for hand and wrist functionality. A simple, quick, and inexpensive test, it takes only a few minutes to complete. In the BBT, a wooden box is divided into two compartments by a partition, and 150 blocks are placed inside. During BBT administration, the patient is position at the table and asked to move as many blocks as possible in 60 seconds between two individual compartments which are equal in size. A client's score is determined by the number of blocks transferred between compartments within 60 seconds. The scores for each hand should be kept separately. Better manual dexterity is reflected in higher scores. When the BBT is being conducted, the evaluator should be aware of whether the client's fingertips cross the partition. In order to count blocks, this condition must be met.

次要结局

  • Visual Analogue Scale (VAS)(2 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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