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Does Prolonged Sitting Pressure Affect Sitting Pressure, Flexibility and Discomfort? ((wheelchair))

2021年2月10日 更新者:Fatma Erdeo、Necmettin Erbakan University

Assessment of Wheelchair First and Last Seating Pressure and Posture and Wheelchair Satisfaction

ntroduction: Pressure sores and postural changes are observed in wheelchair users due to long sitting. Depending on this situation, the quality of life and activity participation level of these individuals decrease.

Method: This study will be conducted between March 1 and June 30, 2021 in Necmettin Erbakan University, Meram Faculty of Medicine, Physical Therapy and Rehabilitation Polyclinic. With the hamstring and trunk flexibility sit-lie test, six sensors placed on the sitting pressure sitting cushion, daily life activity FIM, skill assessment tests will be applied for manual and wheelchair users. Wheelchair Satisfaction CHART and quality of life World Health Organization Quality of Life (Whool ) will be evaluated with.

Application: Patients coming to the center spend 20 minutes on MAT. After resting, FIM will be evaluated with the sit-and-lie test. Afterwards, the patient will be put in a wheelchair. The initial sitting pressure will be taken as soon as you sit in the wheelchair. And at that time, CHART and WHOOL will be completed by asking the patient.

Conclusion: In the light of these evaluations, the change in initial sitting pressure and posture over time will be examined.

研究概览

地位

未知

详细说明

HH.3. Scope:

Which is about 12.29% of the population consists of disabled people in Turkey and the highest rate of disability It is known that physical disability (1). Having at least one wheelchair of approximately 75 million worldwide according to 2019 data plays a critical role in improving mobility (2). In fact, the wheelchair is one of the most widely used assistive technology tools to increase personal mobility and is a precondition for those with limited mobility to enjoy their human rights, live in dignity and become more productive members in their community. For many people, a well-designed and well-equipped wheelchair can be the right step for social inclusion (3). More than half of wheelchair users need assistance with using their wheelchairs and daily living activities (4). The literature investigating the factors affecting wheelchair use mainly consists of variables related to the environment and physical characteristics of wheelchair users (4). Correct selection and configuration of wheelchairs can increase mobility, effectiveness and participation (5).

While sitting comfort is associated with softness and support, lack of support, unbalanced pressure distribution, biomechanics and fatigue factors are associated with sitting discomfort. Anatomical factors can cause characteristic tissue loads that appear to be associated with tissue damage, discomfort, or axillary posture or movement modifications. Following excessive or prolonged tissue loading, cell death may lead to the development of superficial or deep compression wounds (6). A superficial pressure sore first affects the skin layers near the epidermal tissue and is typically associated with damaging friction and shear forces with the presence of moisture and heat (7). Deep compression sores typically begin with the deformation of deep muscle and fat tissues beneath the ischial tuberocytes in the sitting position (8). Although the etiology of pressure sores is multifactorial (9), continuous pressure at the user seat interface is considered the most important factor (10,11). Therefore, wheelchair features are very important for posture and pressure sores. In our study, wheelchair features will be examined and these features will be compared with patient satisfaction. In addition, wheelchair characteristics and patient satisfaction in different patient groups (such as spinal cord injury, Multiple Sclerosis, Cerebrovascular Incident (stroke)) will also be discussed.

Hypotheses Ho: There is no difference between initial sitting pressure and posture in wheelchair users and sitting pressure and posture after 2 and 3 hours.

H1: There is a difference between the initial sitting pressure and posture in wheelchair users and the sitting pressure and posture after 2 and 3 hours.

H2: There is a difference between the initial sitting pressure and posture and the sitting pressure and posture after 2 and 3 hours in different patient groups.

H.4. Method: Individuals Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, Cascioli's study was based on comfort (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be confirmed.

  1. Physical characteristics and history taking: Patients will be asked in detail about age, height, weight, disease diagnosis and duration, and wheelchair characteristics.

    Inclusion criteria were:

    1. Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision,
    2. Being 18 years of age or older,
    3. have used a wheelchair for at least three months,
    4. being dependent on a wheelchair (all day) or at certain times of the day as the primary means of movement, Individuals will be excluded if they have suffered pressure sores within the last year.
  2. Evaluations After taking the patient's history, the person was taken to MAT bed for 20 minutes. will be provided to rest. 20 minutes At the end, the patient who passes to the wheelchair will be asked to evaluate the comfort and discomfort they perceived after the first contact in the chair as 0 (none) -10 (very bad). Grading will be asked to evaluate the discomfort in the head, neck, back, waist, hips and legs, not the general sense of comfort. Meanwhile, pressure and posture will be evaluated.

    • Route-Reach test: This test is used to evaluate hamstring and trunk flexion flexibility. The subject will be asked to sit on the test table with both knees in extension on a firm surface and reach out with his hands and feet without bending the knees. The distance between the fingers and the tip of the test table is measured with a ruler

研究类型

观察性的

注册 (预期的)

15

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, the analysis was made based on comfort data in Cascioli's study (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be determined.

描述

Inclusion Criteria:

Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision, Being 18 years of age or older, have used a wheelchair for at least three months being dependent on a wheelchair as a primary mobility (all day) or at certain times of the day -

Exclusion Criteria:

Individuals will be excluded if they have suffered pressure sores within the past year.

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of Wheelchair First-Last Seating Pressure and Posture and Wheelchair Satisfaction
大体时间:45 minutes
All af study
45 minutes
Sit-Reach test: Pressure Rating: It will be evaluated in kilograms
大体时间:2 two minutes
the value will be recorded in centimeters (cm).
2 two minutes
Pressure Rating
大体时间:3 minutes
It will be evaluated in kilograms
3 minutes

次要结果测量

结果测量
措施说明
大体时间
Evaluation of basic daily living activities (FIM)
大体时间:10 minutes
The total FIM score can range from 18-126.
10 minutes
Craig Handicap Assessment and Reporting Technique (CHART)
大体时间:10 minutes
Has a scale score ranging from 0 to 100
10 minutes
Wheelchair Skills Test (WST) for manual wheelchair users
大体时间:15 minutes
Total WST Capacity Score = total of individual skill points / ([number of possible skills - number of NP points - number of TE points] x 3) X 100%
15 minutes
World Health Organization Quality of Life Scale (WHOQOL):
大体时间:5 minutes
WHOQOL-BREF, unlike the long scale, consists of 4 domains. They do not have separate sections. This scale also has no total score. Each section and area scores a maximum of 20 points or 100 points
5 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Fatma Erdeo, Phd、Necmettin Erbakan University
  • 研究主任:Sami Küçükşen, Prof.、Necmettin Erbakan University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年3月1日

初级完成 (预期的)

2021年6月30日

研究完成 (预期的)

2021年8月30日

研究注册日期

首次提交

2021年2月3日

首先提交符合 QC 标准的

2021年2月10日

首次发布 (实际的)

2021年2月11日

研究记录更新

最后更新发布 (实际的)

2021年2月11日

上次提交的符合 QC 标准的更新

2021年2月10日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • NecmettinNEU

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

When the research is published, I will share my data over Mendeley data sharing.

IPD 共享时间框架

1 year

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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