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临床试验/NCT07019311
NCT07019311尚未招募不适用

Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema

Cairo University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Center of Pressure (COP)

研究概览

简要总结

The purpose of the study is to determine the effect of Thera-band exercises versus Swiss ball exercises on postural stability in unilateral post mastectomy lymphedema.

详细描述

The need for this study develops from the lack of information in the published studies about the effectiveness of Thera-band exercises and Swiss ball exercise on balance in unilateral post mastectomy lymphedema.

Lymphedema is a chronic and progressive condition associated with functional impairment of the body segment.

The asymmetry between hemi Corp related to the range of motion, muscle strength, sensory stimuli and volume, reduce the ability to perceive and integrate information on the maintenance of the center of gravity and postural balance.

The damage in the balance of patients with breast cancer is pointed out in the literature and is related to factors related to surgical intervention, adjuvant treatment, or even unilateral asymmetry caused by upper limb lymphedema.

Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.

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
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients are females.
  • •Patient with post mastectomy unilateral lymphedema.
  • •Their age will range from (30-50) years.
  • •Patients will be given their informed consent.

排除标准

  • •Musculoskeletal disorders that will impair performance during training and tests.
  • •Uncontrolled cardiovascular or pulmonary diseases.
  • •Neurological and renal disorders.
  • •Metabolic or vascular disease with a neurological component such as diabetes.
  • •Malignant conditions.
  • •Primary lymphedema.
  • •Psychiatric illness, severe behavior or cognitive disorders.
  • •Uncooperative patients.
  • •Pregnancy.

研究组 & 干预措施

Thera-Band exercises + Traditional physical therapy program

Experimental

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Thera-Band resistance exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

干预措施: Thera-Band exercises (Other)

Thera-Band exercises + Traditional physical therapy program

Experimental

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Thera-Band resistance exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

干预措施: Traditional physical therapy program (Other)

Swiss ball exercises + Traditional physical therapy program

Experimental

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Swiss ball exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

干预措施: Swiss ball exercises (Other)

Swiss ball exercises + Traditional physical therapy program

Experimental

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Swiss ball exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

干预措施: Traditional physical therapy program (Other)

结局指标

主要结局

Center of Pressure (COP)

时间窗: 8 weeks

The Wii Balance Board (WBB) will be used to measure the Center of Pressure (COP), which represents the point location of the vertical ground reaction force vector. This outcome reflects the user's weight distribution and is a key indicator of balance and postural control. COP will be assessed in both the mediolateral (X-axis: left-right) and anteroposterior (Y-axis: front-back) directions, allowing evaluation of postural sway and dynamic weight shifting during balance tasks.

Total Force (Weight)

时间窗: 8 weeks

Total vertical ground reaction force will be calculated by summing the readings from all four pressure sensors on the WBB. This measure provides an estimate of the user's body weight and enables monitoring of force fluctuations during dynamic or static postural tasks, serving as an indirect marker of load-bearing and movement initiation or compensation patterns.

Load Distribution

时间窗: 8 weeks

The WBB will quantify the distribution of body weight across the left vs. right and front vs. back regions of the platform. This load distribution outcome helps identify asymmetries in stance or postural alignment, which can be critical in populations with balance deficits or musculoskeletal impairments. The measure allows for detailed analysis of postural strategy and weight-bearing preference.

次要结局

  • Limb volume measurement(8 weeks)

研究者

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

Afkar Zaki Abdullah Elbanouby

Principal Investigator

Cairo University

研究点 (1)

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