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临床试验/NCT04941326
NCT04941326招募中不适用

Investigation of the Effect of Spinal Mobilization and Respiration Techniques on Posture and Respiratory Function in Parkinson's Patients

Abant Izzet Baysal University4 个研究点 分布在 2 个国家目标入组 63 人开始时间: 2021年8月15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
63
试验地点
4
主要终点
Pulmonary Function Test

研究概览

简要总结

Parkinson's patients suffer from respiratory distress for different reasons. It is thought that physiotherapy methods that have an indirect effect on the diaphragm can improve respiratory functions. The aim of this study is to investigate the effects of spinal mobilization and diaphragmatic breathing techniques on respiratory function.

详细描述

Respiratory complications are one of the most common causes of death in Parkinson's patients. Camptocormia may develop in Parkinson's disease and other pathological conditions involving the basal ganglia, which can be defined as an abnormal flexion of the thoracolumbar spine of 45° or more, which increases during walking or standing and disappears completely in the supine position. Parkinson's patients with camptocormia often complain of dyspnea, which can be attributed to reduced lung capacity due to limited chest expansion.

Restrictive changes due to respiratory muscle dysfunction in Parkinson's disease, upper airway obstruction, abnormal ventilatory control, and drug use such as levodopa have an effect on respiratory functions.

Restrictive dysfunction has been reported in 28-94% of patients with Parkinson's.

Postural disorders such as camptocormia can also lead to restriction. One study found that the lung volumes of Parkinson's disease patients with camptocormia decreased, although it was not associated with major clinical changes.

Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participans and outcome assessors will be blinded to group allocation. Control group will receive same amount of sham mobilisations.

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been diagnosed with Parkinson's disease
  • Volunteering to participate in the study
  • Modified Medical Research Council (MMRC) score >2

排除标准

  • Those with COVID-19
  • Diseases that increase intra-abdominal pressure
  • Diseases affecting diaphragmatic motility
  • Those who had a recent thoracic or abdominal operation
  • Those who have a parenchymal, pleural or chest wall mass that will cause restriction on a recent chest X-ray or CT will not be included in the study

结局指标

主要结局

Pulmonary Function Test

时间窗: Four weeks

Respiratory function tests will be performed on all individuals with the MIR SPIROLAB II brand pulmonary function test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) results from the test will be used to calculate the ratio of FEV1 to FVC (FEV1/FVC) will be recorded. The combined FEV1/FVC ratio will be used as primary outcome.

次要结局

  • Spinal Mouse Evaluation(Four weeks)
  • Camptocormia and Range of Motion Evaluations(Four weeks)
  • Ultrasonography(Four weeks)

研究者

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

Ramazan KURUL

Assistant Professor

Abant Izzet Baysal University

研究点 (4)

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