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Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

2020年2月6日 更新者：Kardelen Gencer Atalay、Marmara University

Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users

Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.

研究概览

地位

完全的

条件

详细说明

Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA). Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).

研究类型

观察性的

注册 (实际的)

28

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。

学习地点

  • 火鸡
      • Istanbul、火鸡、34899
        • Marmara University

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Prosthesis users with transtibial amputation and their age-, sex- and dominancy-matched (1:1) able-bodied controls to provide an amputation-independent reference were included.

描述

Inclusion Criteria:

  1. Unilateral transtibial amputation on the right side
  2. Using the prosthesis for more than 1 year
  3. Able to use the prosthesis without pain and discomfort
  4. Able to walk without a walking aid

Exclusion Criteria:

  1. Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
  2. Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
  3. Taking medication that is known to affect balance

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

队列和干预

团体/队列
Prosthesis users
Prosthesis users with transtibial amputation
Able-bodied Controls
Prosthesis users' age-, sex- and dominancy-matched healthy controls

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
Ultrasonographic cross-sectional area of rectus femoris measurement
大体时间：through study completion, an average of 6 months
Images were obtained at the bulkiest area of muscle at mid-thigh (midway between the anterior superior iliac spine and the upper pole of the patella) while the participant lay in the supine position with lower limbs are extended and relaxed. The probe was held axially with a light touch in order not to cause any difference in the muscle volume. The rectus femoris cross-sectional area of both limbs (CSA-RF) (mm2) was calculated.
through study completion, an average of 6 months

次要结果测量

结果测量
措施说明
大体时间
Knee extension strength measurement via handheld dynamometer
大体时间：through study completion, an average of 6 months
The dynamometer was located 5 cm above the intermalleolar line to measure bilateral knee extension strength. All participants were tested while lying supine position with a support behind the knees to achieve approximately 30° of flexion. For the amputated-limb, the prosthesis was used in place.
through study completion, an average of 6 months
Step-up-over Test
大体时间：through study completion, an average of 6 months
All participants were asked to stand still behind the box placed on the pressure platform and to move immediately after seeing the sign on the computer screen. The movement was defined as three phases: first stepping onto the box with one limb, second carrying the body over the box, and third landing with the other limb on the opposite side of the box. The average lift-up index (%), movement time (s), and the impact index for both limbs calculated after three repetitions.
through study completion, an average of 6 months
Walk-across Test
大体时间：through study completion, an average of 6 months
All participants were asked to stand still and to walk as fast as possible along with the pressure platform after seeing the sign on the computer screen. The average step width (cm), step length (cm), and speed (cm/s) were calculated after three repetitions.
through study completion, an average of 6 months

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。

赞助

Marmara University

调查人员

  • 首席研究员：Kardelen Gencer Atalay、Marmara University

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 (实际的)

2018年10月1日

初级完成 (实际的)

2019年4月1日

研究完成 (实际的)

2019年5月1日

研究注册日期

首次提交

2020年2月6日

首先提交符合 QC 标准的

2020年2月6日

首次发布 (实际的)

2020年2月10日

研究记录更新

最后更新发布 (实际的)

2020年2月10日

上次提交的符合 QC 标准的更新

2020年2月6日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 09.2018.025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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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