The Assessment of Talar Cartilage, Tibialis Antetior and Gastrocnemius Muscles in Patients With Unilateral Traumatic Transtibial Amputation: a Clinical and Sonographic-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements
研究概览
简要总结
Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower limb amputation. Although there are many studies on knee joint of intact limb of amputees in the literature, the number of studies on intact foot and ankle is extremely limited. The primary aim of the study is to compare the intact talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee patients with that of healthy individuals using ultrasound. The secondary aim is to investigate the relationship between cartilage and muscle thickness measurements with clinical parameters.
详细描述
Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body mass index (BMI)-matched male controls will be participated in this cross-sectional study. Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18-65
- •Patients who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation
- •Patients who have been using prostheses for at least 3 months
排除标准
- •Bilateral amputation
- •Previous history of any trauma/surgical history of the lower extremities (other than amputation)
- •Rheumatic diseases
- •Contracture of the knee and the ankle of the intact limb
结局指标
主要结局
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements
时间窗: through study completion, an average of one and a half months
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.
次要结局
- 6-minute walking test(through study completion, an average of one and a half months)
- Short Form-36 (SF-36)(through study completion, an average of one and a half months)
- The Foot and Ankle Outcome Score (FAOS)(through study completion, an average of one and a half months)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital