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临床试验/NCT04757064
NCT04757064Unknown不适用

Efficacy of Selected Exercise Program on Distal End Femoral Sarcoma Patients Undergoing Knee Modular Endoprosthesis: RCT

Cairo University0 个研究点目标入组 40 人开始时间: 2021年8月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
ROM

研究概览

简要总结

This study will be conducted to investigate the effect of selected therapeutic exercises compared to standard exercise program in improving ROM, muscle strength and functional outcomes in distal femur osteosarcoma patients who have undergone tumor resection and modular knee endoprosthesis.

详细描述

Osteosarcomas (OS) are the most common primary bone tumor and third most common cancer among children and adolescents after lymphomas and brain cancers (Wang et al., 2018; Luetke et al., 2014).

It is a primary malignant bone tumor with a worldwide incidence of 3.4 per million people per year (Mirabello et al., 2009). They are characterized by the production of osteoid, or immature bone, by malignant mesenchymal cells (Wang et al., 2018; (Luetke et al., 2014).

Patients displayed some persisting physical difficulties including incapability to perform active range of motion (ROM), decreased muscle strength, altered gait and sit-to-stand patterns, yet they maintained high levels of emotional acceptance and coping. A surprising but important finding was the persisting hip weakness in both operated and non-operated limbs, which extends up to 42 months after resection around the knee. This indicates that continued rehabilitation programs emphasizing hip strengthening should be considered for these patients, even years after surgery (Beebe et al., 2009). Furthermore, ROM exercises, strengthening exercises and balance exercises improve overall Quality of life (QOL) for these patients (Marchese et al., 2006).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as distal femur osteosarcoma. 2) Age of the patient from 15-50 years old 3) Patients undergoing tumor resection and knee endoprosthetic reconstruction six weeks ago. 4) Both gender

排除标准

  • Lung and bone metastasis 2) End stage patients receiving palliative chemotherapy 3) Patients undergoing L.L amputation or rotationplasty (any surgical procedures rather than knee endoprosthetic reconstruction). 4) Local tumor recurrence 5) Sever psychiatric illness 6) Heart disease or any condition that prevent the patient from participation in exercise

结局指标

主要结局

ROM

时间窗: 3 minutes

knee flexion and extension ROM measured by goniometer

knee extensor muscle strength

时间窗: 5 minutes

measuring rectus femoris muscle strength by manual muscle testing

次要结局

  • functional outcome(2 minutes)

研究者

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

Gamila Saleh Tammam Abbas

orthopedic physical therapist

Cairo University

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