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临床试验/NCT06293443
NCT06293443Unknown不适用

Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study

Medipol University2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
2
主要终点
Amputee Mobility Scale

研究概览

简要总结

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

详细描述

The study will be carried out at Medicom Orthosis Prosthesis Center and Ortoport Prosthesis Application Center. The study will be conducted in accordance with the principles of human experimentation as defined in the Declaration of Helsinki. For this purpose, amputees who will participate in the study will be given detailed information about the study and will have to sign an informed consent form. 20 unilateral lower extremity amputations will be taken. The inclusion and exclusion criteria of the study are as follows; Inclusion criteria;

Unilateral lower extremity amputation, Using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities,

Exclusion criteria; Bilateral lower extremity amputation, Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease,

SPPS 25.0 (Statistical Package for the Social Sciences) statistical package program will be used to evaluate the data. When the differences between two groups are desired to be evaluated, "Student's t Test" is used if it meets the parametric test prerequisites; If not, the "Mann Whitney-U test" will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

participants underwent functional testing at clinical centers

入排标准

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

入选标准

  • Unilateral lower extremity amputation,
  • Being using a prosthesis,
  • Being literate,
  • Being between the ages of 18-65,
  • Having a healthy stump,
  • Using your current prosthesis in daily living activities,

排除标准

  • Bilateral lower extremity amputation
  • Unilateral or bilateral amputation of the upper extremity,
  • Having a cognitive or mental problem,
  • Having serious hearing and vision problems,
  • The individual has an orthopedic disease other than amputation,
  • Having an uncontrolled neurological and systemic systemic disease,

研究组 & 干预措施

Lower extremity unilateral amputee

Other

Unilateral transtibial and unilateral transfemoral amputees were evaluated in the study. Criteria for autees to participate in the study; Being a unilateral lower extremity amputee, using a prosthesis, being literate, being between the ages of 18-65, having a healthy stump, and using their current prosthesis in daily life activities. Individuals who had knee disarticulation amputation and individuals who had hip disarticulation amputation were not included in the study.

干预措施: Lower extremity unilateral amputee (Other)

结局指标

主要结局

Amputee Mobility Scale

时间窗: 2 weeks

It is a 21-item scale that evaluates static and dynamic balance. It is also used to predict the amputee's potential ambulation level. It is also a scale used to evaluate function during or after rehabilitation. Questions include sitting balance, transfers, standing balance, walking, stairs, assistive device use. Scoring is made between 0-47.

次要结局

  • One Leg Standing Test(2 weeks)
  • Houghton Scale(2 weeks)
  • l test(2 weeks)
  • 10 Meter Walking Test(2 weeks)
  • 8-Shape Walking Test(2 weeks)
  • joint range of motion(2 weeks)
  • proprioception(2 weeks)

研究者

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

Tugba Tanis

Principal Investigator

Medipol University

研究点 (2)

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