跳至主要内容
临床试验/NCT04262297
NCT04262297已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年10月1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
28
试验地点
1
主要终点
Ultrasonographic cross-sectional area of rectus femoris measurement

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Ultrasonographic cross-sectional area of rectus femoris measurement

时间窗: 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.

次要结局

  • Step-up-over Test(through study completion, an average of 6 months)
  • Knee extension strength measurement via handheld dynamometer(through study completion, an average of 6 months)
  • Walk-across Test(through study completion, an average of 6 months)

研究者

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

Kardelen Gencer Atalay

Principal Investigator

Marmara University

研究点 (1)

Loading locations...

相似试验

Rectus Femoris Thickness Measurement in Unilateral... | 临床试验