Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
This research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues.
详细描述
By combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients diagnosed with Calf Strain and Spasm
- •Age above 18
- •Participants who are volunteer for the study
- •Patients who suffer from leg pain or functional disability
排除标准
- •Unconscious patients
- •Patients with difficulty in seeing and hearing
- •Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
- •Patient history of severe mobility disorder
- •Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
- •Decline to participate in this study
- •Active fracture and dislocations
- •Arthritic disorders (such as osteoarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, and Fibromyalgia)
结局指标
主要结局
Visual Analog Scale
时间窗: 12 Months
subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 for "no pain" and 10 for "worst pain".
Functional Disability Scale for Ankle (FADI)
时间窗: 12 months
The FADI has 26 items. Each item is scored from 0 (unable to do) to 4 (no difficulty at all). The 4 pain items of the FADI are scored 0 (unbearable) to 4 (none). The FADI has a total point value of 104 points, whereas the FADI Sport has a total point value of 32 points.
Range of motion (ROM)
时间窗: 12 months
This tool measures the angle of dorsiflexion before and after the intervention, offering insights into the functional improvements resulting from the use of the portable wedge device. Additionally, participant satisfaction and compliance will be assessed through a structured questionnaire.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University