Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assess the dorsal flexion with numerical scale of range of motion
研究概览
简要总结
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain.
Design: Case-control study. Objective: To observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality.
Patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage.
Measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (RS SCAN® model platform), and functionality (2 Minute Walk Test).
Expected results: Analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemophilia A and B.
- •Over 18 years.
- •With medical diagnosis of ankle arthropathy.
- •With clinical evaluation by Hemophilia Joint Health Score.
- •In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
- •No previous hemarthrosis of the ankles in the 3 months prior to evaluation.
排除标准
- •Patients with inhibitors (antibodies against FVIII or FIX).
- •Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests.
- •Failure to sign the informed consent document
结局指标
主要结局
Assess the dorsal flexion with numerical scale of range of motion
时间窗: Screening visit
Measurement with Leg Motion system. Subjects will stand with the big toe on the starting line and the knee touching a metal stick. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot.
Assess the dorsiflexion strength with dynamometry
时间窗: Screening visit
The maximal isometric strength of the ankle flexor muscles will be tested. Both extremities will be evaluated with a manual dynamometer (model Lafayette Manual Muscle Tester 01165). The examiner will hold the dynamometer on the sole of the foot while the subject exerts maximal force against it. The unit of measurement of this measurement instrument is the Newton per square centimeter (N/cm2), where the higher the score, the greater the muscle force.
次要结局
- Assess the biomechanical analysis of gait and balance with pressure platform(Screening visit)
- Assess the functionality with pressure platform(Screening visit)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
University of Oviedo