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临床试验/NCT06065423
NCT06065423已完成不适用

Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

Marmara University3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9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
40
试验地点
3
主要终点
Symptom Severity

研究概览

简要总结

During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

详细描述

Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who had undergone breast surgery at least 3 months ago
  • Had stage 1-2 lymphedema
  • Had upper extremity lymphedema associated with breast cancer

排除标准

  • Signs of infection such as lymphangitis, cellulitis, fungal infections
  • Those with documented lymph node metastases
  • Those with bilateral lymphedema
  • Those with other diseases affecting upper extremity functions
  • Those with a history of previous surgery related to the upper extremity

结局指标

主要结局

Symptom Severity

时间窗: Time Frame: 8 weeks

Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)

Functionality

时间窗: Time Frame: 8 weeks

Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire

Efficacity

时间窗: Time Frame: 8 weeks

Lymphedema Quality of Life Impact Scale

Volume Measurements

时间窗: Time Frame: 8 weeks

Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3

次要结局

  • Patient satisfaction with the treatment(Time Frame: 8 weeks)
  • patients were asked to compare their hand functionality to before the injury(Time Frame: 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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