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临床试验/NCT04903392
NCT04903392Unknown不适用

Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients

Bandırma Onyedi Eylül University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
28
试验地点
2
主要终点
Pulmonary function (Forced expiratory volume in the first second (FEV1))

研究概览

简要总结

Loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. Post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. It was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. A systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. Learning to walk backwards is also recommended to improve the movement components required for walking forward. As a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. Therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.

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)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study
  • More than 6 months have passed since the onset of stroke
  • First time stroke diagnosis
  • Being between the ages of 40-65
  • Spasticity severity in lower extremity less than 3 according to Modified Ashworth Scale,
  • Being medically stable
  • Ability to walk 10 meters and above without assistance

排除标准

  • Presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs
  • Uncontrollable Hypertension
  • Having been diagnosed with any pulmonary disease
  • Severe cardiac conditions
  • Uncontrollable DM
  • Lack of cooperation

结局指标

主要结局

Pulmonary function (Forced expiratory volume in the first second (FEV1))

时间窗: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.

Plantar pressure assessment

时间窗: 6 weeks

Plantar pressure distribution will be evaluated.

Pulmonary function (Forced vital capacity (FVC))

时间窗: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.

Pulmonary function (FEV1 / FVC)

时间窗: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.

Pulmonary function (Peak flow rate (PEF))

时间窗: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

Respiratory Muscle Strength

时间窗: 6 weeks

Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device

Balance assessment

时间窗: 6 weeks

Static and dynamic balance will be evaluated with The Korebalance Premiere device.

Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

时间窗: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.

次要结局

未报告次要终点

研究者

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

Burçin Akçay

Assistant Professor

Bandırma Onyedi Eylül University

研究点 (2)

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