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临床试验/NCT06977620
NCT06977620已完成不适用

Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Kinesis Balance™ fall prevention app

研究概览

简要总结

Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. closed kinetic chain (CKC) exercises play a crucial role in enhancing musculoskeletal stability by countering gravitational forces during both rest and movement. weight shifting and balance are fundamental components of functional movement. Proprioceptive training, which focuses on improving body awareness and balance, is essential for developing trunk control

详细描述

Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups.

1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.

1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.

1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks.

1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).

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
Single (Outcomes Assessor)

盲法说明

Double blind study design. Randomization and masking were performed by an independent investigator who was not engaged in either the treatment administration or the outcome assessment

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who had a history of BCRS with upper limb lymphedema. • Age range of 40-60 years.
  • The body mass index (BMI) is less than 30 Kg/m
  • Consciousness and ability to communicate orally or in writing.
  • Treatment by unilateral mastectomy with lymph node dissection.
  • No obvious abnormal spine morphology or postural abnormalities visible to the naked eye.
  • All participants had moderate lymphedema according to the lymphedema severity assessment.

排除标准

  • Patients with metastases. • Differences between lower limb length.
  • Having acute or chronic vestibular, neurological, and orthopedic diseases.
  • Surgery related to spine causing limitation of motion.
  • Women with psychiatric disorders, reconstructive surgery.
  • Bilateral mastectomy. Diagnosis with a neurological, skeletal, or rheumatic disorder or other disease that seriously affects body posture.
  • History of bodily injury such as a spinal, shoulder, or neck injury, resulting in permanent alteration of the normal body posture prior to the unilateral mastectomy.
  • Failure to complete follow-up for any reason over the course of the study.
  • Peripheral polyneuropathy, cognitive dysfunction.
  • Patients taking medication that affects body balance.
  • Severe arthritis or orthopedic conditions in their lower extremity
  • Poor conditioning, acute pain in any reason,
  • Neurological disorders including visual problems.

研究组 & 干预措施

Group B (WS group):

Active Comparator

This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.

干预措施: Weight shifting exercises (Other)

Group B (WS group):

Active Comparator

This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.

干预措施: Complete Decongestive Therapy (Other)

Group C (Combined group)

Active Comparator

This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks

干预措施: Closed kinetic chain exercises (Other)

Group C (Combined group)

Active Comparator

This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks

干预措施: Weight shifting exercises (Other)

Group C (Combined group)

Active Comparator

This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks

干预措施: Complete Decongestive Therapy (Other)

Group A (CKC group)

Active Comparator

This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.

干预措施: Closed kinetic chain exercises (Other)

Group A (CKC group)

Active Comparator

This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.

干预措施: Complete Decongestive Therapy (Other)

Group D (control group)

Placebo Comparator

This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).

干预措施: Complete Decongestive Therapy (Other)

结局指标

主要结局

Kinesis Balance™ fall prevention app

时间窗: Eight weeks

Patients will be instructed to hold the phone firmly against their sternum and stand with their eyes open, in a semi-tandem stance, for 30 s. The app contains audio and visual instructions on how to prepare for and complete the test as well as an audio cue to indicate test start and stop.

次要结局

  • Time Up and Go Test (TUG)(Eight weeks)
  • Functional Reach Test (FRT)(Eight weeks)

研究者

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

Aya Kamal Mousa Mohamed

Assistant lecturer

Cairo University

研究点 (1)

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