跳至主要内容
临床试验/NCT04421807
NCT04421807Unknown不适用

Investigation of the Effects of Scapulathoracic Stabilization Exercises Additionally Applied to Complex Decongestive Therapy After Mastectomy on Posture, Balance and Quality of Life

Ataturk Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Thoracic khyphosis

研究概览

简要总结

The aim of the study is to investigate the effects of scapulathoracic stabilization exercises additionally applied to complex decongestive therapy after mastectomy on posture, balance and quality of life.

详细描述

Lymphedema is a chronic and progressive condition that occurs with the accumulation of protein-rich fluid in interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary. Secondary lymphedema is the most common form seen in upper extremity, usually after breast cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture, balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce edema, however, there were insufficient studies investigating the effects on the posture and the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to increase muscle stability ability, kinesthetic awareness, ovarall stability and balance. However, when the literature is reviewed, no study is found investigating the effect of scapulatoracic stabilization exercises in individuals who developed lymphedema after mastectomy.

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
None

入排标准

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

入选标准

  • 18 to 65 years of age
  • Agree to participate in the study,
  • Undergoing unilateral mastectomy due to breast cancer treatment and additionally development of limb lymphedema,
  • Lymphedema stage 2 and 3,
  • Being a woman,
  • Having spent at least 6 months after the operation
  • With or without radiotherapy and / or chemotherapy.

排除标准

  • Irregular participation to the treatment program,
  • Severe heart failure and / or rhythm disturbance,
  • Uncontrolled hypertension,
  • Presence of metastasis,
  • Infection in the affected arm,
  • Any problems that may affect balance (rheumatological, vestibular, visual, neurological),
  • Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may affect the balance and posture negatively.
  • Presence of spinal deformity,
  • Those who have had spinal surgery in the last 6 months.

结局指标

主要结局

Thoracic khyphosis

时间窗: change from baseline , at 4 weeks and at 8 weeks

Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).

Posture angle

时间窗: change from baseline , at 4 weeks and at 8 weeks

Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone

General posture status

时间窗: change from baseline , at 4 weeks and at 8 weeks

General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.

次要结局

  • The severity of the lymphoedema(change from baseline , at 4 weeks and at 8 weeks)
  • Balance(change from baseline , at 4 weeks and at 8 weeks)
  • Quality of life outcomes(change from baseline , at 4 weeks and at 8 weeks)
  • Lymphedema symptoms(change from baseline , at 4 weeks and at 8 weeks)
  • Range of motion of shoulder(change from baseline , at 4 weeks and at 8 weeks)
  • Scapulatoracic muscle strength(change from baseline , at 4 weeks and at 8 weeks)
  • Scapular dyskinesia(change from baseline , at 4 weeks and at 8 weeks)
  • Upper extremity functions(change from baseline , at 4 weeks and at 8 weeks)

研究者

发起方
Ataturk Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seyda TOPRAK CELENAY

Associate Professor

Ataturk Training and Research Hospital

研究点 (2)

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