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临床试验/NCT06738147
NCT06738147尚未招募不适用

"Effect of Pelvic Floor Muscle Training on Postural Balance and Fall Risk in Postmenopausal Females With Urinary Incontinence"

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1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
30
试验地点
1
主要终点
pelvic floor muscle activity

研究概览

简要总结

Understanding the relationship between Pelvic floor muscle dysfunctions as stress urinary incontinence with Postural balance ability and subsequent fall risk in postmenopausal females is important in terms of injury prevention and decrease morbidity and mortality rate among postmenopausal females. Therefore, this study investigating the effect of pelvic floor muscle training on postural balance and fall risk in postmenopausal females with stress urinary incontinence.

详细描述

Thirty post-menopausal females will participate in this study. They will be selected from the outpatient clinic at Daraya University.They will be randomly assigned in two groups experimental (A) and control (B) group, each group will have (15) postmenopausal female. Experimental Group (A):

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Control Group (B):

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by traditional physical and balance training program only (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

All females in both groups will be evaluated for urinary incontinence through ultrasonography and pelvic floor bother questionnaire (PFBQ) at the beginning of the study and at the end of treatment period. Also, static, and dynamic balance performance and fall risk will be assessed in the beginning of the study and at the end of treatment period through the Biodex balance system and Tinetti Performance Oriented Mobility Assessment (POMA). All participants will be given an explanation of study protocol, and an informed consent form will be signed by each female

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •All females will be postmenopausal.
  • •Their ages will range from: 50-60 years.
  • •Their BMI will be less than 30 kg\m
  • •All females will be suffering from urinary incontinence.
  • •All females will be sedentary.
  • •All females will have balance disorders. 7.All females will be able to walk across a small room without an assistive device.

排除标准

  • •History of lower extremity injury, surgery or pain during ADL.
  • •Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance.
  • •Women with mild, moderate and severe cognitive deficits.
  • •Women with neurological diseases, including conditions after a Stroke.
  • •Females with a history of brain injury.
  • •Females with significant visual and hearing damage confirmed by neurological examination.
  • •Females with serious internal orthopedic and oncological diseases.

研究组 & 干预措施

Experimental Group (A)

Experimental

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

干预措施: pelvic floor muscle training (Other)

Experimental Group (A)

Experimental

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

干预措施: balance exercises (Other)

Control Group (B)

Other

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by traditional physical and balance training program only (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

干预措施: balance exercises (Other)

结局指标

主要结局

pelvic floor muscle activity

时间窗: 3 months

Assessment of pelvic floor muscle by Ultrasound imaging device, it will be used to assess PFM activity by measuring bladder base displacement (as a marker for PFM activity)

antero posterior stability index

时间窗: 3 months

Indicator for dynamic postural stability

Medio lateral stability index

时间窗: 3 months

Indicator for dynamic postural stability

Overall stability index

时间窗: 3 months

Indicator for dynamic postural stability

stability an sway indexes

时间窗: 3 months

Indicator for fall risk

次要结局

未报告次要终点

研究者

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

Hager Mohey Eldien Abdel Aziz Mahmoud

Assistant lecturer of physical therapy for woman health at deraya university

Cairo University

研究点 (1)

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