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临床试验/NCT04220541
NCT04220541已完成不适用

Investigation of the Effects of Different Exercise Programs on Patients With Chiari Malformation Type 1

Hacettepe University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年7月6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
16
试验地点
2
主要终点
Neck Disability Index

研究概览

简要总结

Chiari Malformation (CM) is a posterior brain anomaly caused by the displacement of the brain stem and cerebellum into the cervical spinal canal. There are 8 types of Chiari malformations described today that vary according to the severity of the anomaly.

In CM Type 1, cerebrospinal fluid (CSF) circulation deteriorated along with the foramen magnum and the cerebellar tonsillar decreased to at least 5 mm below the foramen magnum. Depending on this situation, headache, cerebellar findings, muscle strength, and sensory loss and so on. and adversely affect the daily life of the patient.

When establishing an exercise program for the symptoms of CM type 1, it should be taken into consideration that somatosensory, visual, vestibular system and cerebellum are in close relationship with each other and balance and coordination result from this close relationship.

When the literature is reviewed for exercise programs aimed at reducing instability in the cervical region, it is seen that 80% of the stability of the cervical spine originates from the muscular system and its importance in the treatment process is being investigated more and more day by day. However, no randomized controlled study was performed on these subjects. This study was planned to investigate the effects of two different exercise programs on pain, balance, coordination, proprioception, functional capacity, body posture, daily life activities and quality of life. The study was planned to involve at least 20 individuals with CM Type 1 who were not surgical indications in the 18-65 age range. The study was designed as a randomized, self-controlled study. Demographic data and characteristics of the subjects who meet the inclusion criteria and agree to participate in the study will be recorded at the beginning of the study. Patients will be evaluated in two different time periods. The first evaluations will be performed on the first day when patients are referred to rehabilitation by the physician. Following this assessment, all patients will be assigned numbers, which will be divided into two groups using a simple randomization method in the form of drawing lots. A total of 18 sessions 3 times a week for six weeks, the first group will receive symptomatic exercise program and the second group will focus on the deep muscles in the cervical region, especially the stabilizer, and a "Motor learning-based" exercise program that includes gradual control of these muscles. After 6 weeks, the first evaluations will be repeated in both groups.

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

  • The study was planned to involve at least 20 individuals with CM Type 1 who were not surgical indications in the 18-65 age range.

排除标准

  • Motor type defect due to CM Type 1,
  • Presence of primary neurological disease other than CM Type 1, severe cognitive impairment (> 24 from the Mini Mental State Assessment),
  • peripheral vestibular problem and history of orthopedic surgery,
  • patients who had musculoskeletal problems in the last 6 months and who received physiotherapy rehabilitation program in the last 6 months,

结局指标

主要结局

Neck Disability Index

时间窗: 6 weeks

The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. ... Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache.

Visual Analog Scale

时间窗: 1 week

A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

次要结局

  • Berg Balance Scale(6 weeks)
  • Posture Screen Mobile(24 hours)
  • Short Form-36(4 weeks)
  • International Cooperative Ataxia Rating Scale(6 weeks)

研究者

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

Ceyhun Turkmen

Research Assistant

Hacettepe University

研究点 (2)

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