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The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation

2026年6月30日 更新者：Asli Bebek、Hacettepe University

This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes.

Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device.

The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

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。

学习联系方式

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

This study population consists of adults aged 18-65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Participants are recruited from clinical and rehabilitation settings and meet predefined inclusion and exclusion criteria. All individuals undergo a single-session assessment to evaluate postural control, pain, daily living activities, hand function, and reaction time.

描述

Inclusion Criteria:

  • Adults aged 18-65 years
  • Unilateral upper limb amputation
  • Use of a myoelectric or bionic prosthesis for at least 1 year
  • Current prosthesis use for a minimum of 3 months

Exclusion Criteria:

  • Bilateral upper limb amputation
  • Additional amputation of another limb
  • Use of passive or cosmetic prosthesis
  • Presence of neurological or other significant orthopedic disorders unrelated to amputation

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
干预/治疗
Unilateral Upper Limb Amputation Group

Participants in this cohort are adults aged 18 to 65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Individuals must have been using their current prosthesis for at least three months and have a minimum of one year of prosthesis experience. Participants with additional neurological or orthopedic conditions, bilateral amputation, or passive/cosmetic prosthesis use are excluded.

This is an observational study. No interventional procedures are performed. All participants undergo a single assessment session including measurements of postural control, posture, neck and low back pain, daily living activities, hand dexterity, and reaction time.
其他：This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.
This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.

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
Daily living activity score
大体时间：through study completion, an average of 1 year
In upper extremity amputees, daily living activities and occupational skills will be assessed using a questionnaire. (0-100 score, Survey on Activities of Daily Living and Occupations of Upper Extremity Amputees)
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Postural Sway and Limits of Stability
大体时间：through study completion, an average of 1 year
Postural sway (cm) measured using a force BERTEC platform system.
through study completion, an average of 1 year
Postural Sway and Limits of Stability
大体时间：through study completion, an average of 1 year
limits of stability (%) measured using a force BERTEC platform system.
through study completion, an average of 1 year
Neck and Back Pain Intensity
大体时间：through study completion, an average of 1 year
Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
through study completion, an average of 1 year
Hand Dexterity
大体时间：through study completion, an average of 1 year
easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
through study completion, an average of 1 year
Reaction Time
大体时间：through study completion, an average of 1 year
Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
through study completion, an average of 1 year

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

Hacettepe 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)

2026年1月1日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年2月14日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6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

  • FTREK25/28

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

. The study includes sensitive clinical and functional assessment data collected at a single center. All data will be securely stored and used solely for research purposes in accordance with ethical approval and institutional regulations.

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

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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