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临床试验/NCT07364279
NCT07364279已完成不适用

Effect of Wii Fit Balance Board Games on Balance in Patients With Osteoporosis Post Mastectomy

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月5日最近更新:
适应症
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
Berg Balance Scale (BBS).

研究概览

简要总结

This study will be a randomized controlled trial. The purpose of the study is to evaluate the therapeutic effect of Wii Fit balance board games on balance in patients with osteoporosis post mastectomy.

详细描述

Women with breast cancer face an increased risk of osteoporosis, necessitating screening and treatment to prevent fractures due to aging and treatment effects. Osteoporosis exacerbates balance issues, raising fall risks among these patients. The treatments often lead to accelerated bone loss and compromised musculoskeletal support, amplifying their vulnerability to fractures. Integrated management strategies that enhance bone health and balance rehabilitation are essential for this group. Post-mastectomy systematic movement exercises are vital for maintaining activity and preventing posture issues, significantly improving balance. Additionally, the use of interactive systems like Wii Fit has shown to effectively aid balance training and improve overall physical function for breast cancer patients, making it a valuable component of at-home rehabilitation programs to reduce fall risk and enhance quality of life.

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 (Participant)

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

  • The subject selection will be according to the following criteria:
  • All patients are female.
  • Age ranges from 40_60 years.
  • All patients suffering from balance dysfunctions resulting from osteoporosis after mastectomy.
  • All participants will have informed consent to participate in this study.
  • All patients will participate in the study after 6 months of receiving chemotherapy and diagnosed with osteoporosis.
  • All patients will follow the same diet .
  • Ability to stand and ambulate independently

排除标准

  • Patients will be excluded from the study if they met any of the following criteria:
  • Patients with visual or hearing, vestibular impairment. 25
  • Patients with Previous breast cancer surgery on the present or contralateral side.
  • Patients receiving hormonal therapy
  • Patients with Active or metastatic cancer focus.
  • Patients with Venous thrombosis.
  • Osteoarticular and/or Rheumatological disorders, significantly disturbing balance.
  • Patients with severe orthopedic injuries to the lower extremities (e.g. Ankle fracture, joint fusion or joint replacement).
  • Patients with neurological disturbances that cause impaired balance such as hemiparesis, ataxia, vertigo and vestibular disturbances.
  • Patients with mental disorders.
  • Pregnant patients.
  • Patients with diabetes mellitus.

研究组 & 干预措施

Study group (Wii Fit group

Experimental

This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive Wii Fit balance board exercises for 3 sessions per week for 8 weeks, in addition to traditional balance exercises and the routine medical treatment.

干预措施: Wii fit balance board (Device)

Study group (Wii Fit group

Experimental

This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive Wii Fit balance board exercises for 3 sessions per week for 8 weeks, in addition to traditional balance exercises and the routine medical treatment.

干预措施: traditional balance exercise (Other)

Study group (Wii Fit group

Experimental

This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive Wii Fit balance board exercises for 3 sessions per week for 8 weeks, in addition to traditional balance exercises and the routine medical treatment.

干预措施: Calcium supplement (Drug)

Control group:

Active Comparator

This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive traditional balance exercises in addition to the routine medical treatment for 3 sessions per week for 8 weeks.

干预措施: traditional balance exercise (Other)

Control group:

Active Comparator

This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive traditional balance exercises in addition to the routine medical treatment for 3 sessions per week for 8 weeks.

干预措施: Calcium supplement (Drug)

结局指标

主要结局

Berg Balance Scale (BBS).

时间窗: at baseline and after 8 weeks

The Berg Balance Scale consists of 14 items, each scored on an ordinal scale from 0 to 4 (0 = unable to perform, 4 = normal performance). Document the baseline scores for each item. Tasks Included: Sitting balance. Standing balance. Dynamic balance. Scoring: Total possible score is 56 points. Higher scores indicate better balance. Post-Treatment Assessment: Re-evaluate the patient using the same BBS after eight weeks of treatment.

次要结局

  • assessment of balance using the Wii Fit balance board(at baseline and after 8 weeks)

研究者

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

linda raafat daniel

principal investigator

Cairo University

研究点 (1)

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