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临床试验/NCT06457659
NCT06457659进行中(未招募)不适用

Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Superior University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
World Health Organization Quality of life (WHO QOL)

研究概览

简要总结

A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

详细描述

Along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. Pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be affected. There is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male and female below-knee amputees due to trauma and diabetes were included

排除标准

  • •patients with comorbidities and old users of prostheses were excluded

研究组 & 干预措施

Early Rehab Group

Experimental

干预措施: Early Rehab Group (Behavioral)

Delayed Rehab Group

Other

干预措施: Delayed Rehab Group (Other)

结局指标

主要结局

World Health Organization Quality of life (WHO QOL)

时间窗: 12 Months

Questionnaire was used to measure the impact in both groups on quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality-of-life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health is assessed separately in WHO\_QOL known as the 4 domains of the questionnaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health about the respective domain.

次要结局

未报告次要终点

研究者

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

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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