Development and Validation of a Multimodal Physiotherapy Framework to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cobb's Angle
研究概览
简要总结
Postural hyperkyphosis is common in postmenopausal women and leads to spinal dysfunction, pain, impaired balance, and increased fall risk. This study aims to develop and validate a multimodal physiotherapy framework to prevent and manage hyperkyphosis in this population. A randomized controlled trial will be conducted at Allied Hospital with 72 postmenopausal women aged 40-75 years, divided into intervention (multimodal physiotherapy with conventional care) and control (conventional care only) groups.
详细描述
The intervention includes strength, flexibility, postural correction, and balance training. The primary outcome is the change in Cobb's angle measured via radiographs; secondary outcomes include functional mobility and balance assessments using the Timed Up and Go Test, Berg Balance Scale, and Functional Reach Test. Data will be analyzed using SPSS v26. The study is expected to show significant improvements in spinal alignment, strength, balance, and reduced fall risk. The framework may offer a cost-effective, evidence-based approach for clinical and community rehabilitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged 50-70 years.
- •Kyphotic angle ≥40°, as measured by a flexicurve ruler or radiographic assessment.
- •Postmenopausal for at least one year.
- •Able to engage in rehabilitation exercises and follow instructions for physical activity..
- •Living independently and capable of attending regular physiotherapy sessions.
排除标准
- •Uncontrolled comorbidities such as cardiovascular disease, neurological disorders stroke or Parkinson's), or severe musculoskeletal conditions (e.g., advanced arthritis )
- •History of spinal surgery within the last 6 months or spinal surgical implants. Severe osteoporosis (T-score < -2.5) and a history of multiple fractures.
- •Pregnant or breastfeeding women. Cognitive impairments or mental health disorders that hinder adherence to the intervention.
- •Inability to perform the exercises due to pain or disability.
- •Participation in other rehabilitation or physiotherapy interventions for postural hyperkhyposis
结局指标
主要结局
Cobb's Angle
时间窗: 18 Months
Cobb's Angle is a radiographic measurement used to assess spinal curvature in conditions like hyperkyphosis and scoliosis. It is calculated by identifying the most tilted vertebrae at the top and bottom of the curve on an X-ray. Straight lines are drawn along their endplates, and perpendiculars from these lines intersect to form the Cobb's Angle. A normal thoracic kyphosis ranges from 20° to 40°, while angles exceeding 40° in adults or 50° in postmenopausal women indicate hyperkyphosis. Severe cases (\>60°) may require medical intervention. Regular follow-ups help monitor treatment effectiveness in reducing spinal curvature.
Timed Up and Go (TUG) Test
时间窗: 18 Months
The TUG test assesses mobility, balance, and fall risk in older adults. The patient starts seated in a chair, stands up, walks 3 meters (10 feet), turns around, walks back, and sits down. The time taken to complete the task is recorded in seconds. A score of \<10 seconds indicates normal mobility, 10-20 seconds suggests mild mobility impairment, and \>30 seconds signifies a high fall risk and functional dependence. It is a simple, reliable tool commonly used in rehabilitation settings.
Berg Balance Scale (BBS)
时间窗: 18 Months
The BBS is a 14-item test used to assess balance and fall risk in older adults and neurological patients. Each task, such as standing on one foot or reaching forward, is scored from 0 to 4, with a total score of 56. A score of 41-56 indicates low fall risk, 21-40 suggests moderate risk, and ≤20 signifies a high risk of falls. The test is widely used due to its strong reliability and validity in clinical practice.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University