Analysis of Clinical, Functional and Musculoskeletal Variables Between Adult Patients With Hemophilic Arthropathy of the Knee and Ankle and Their Healthy Peers. A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Assess the muscle strength
研究概览
简要总结
Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.
Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.
Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.
Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).
Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.
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
- 否
入选标准
- •Patients diagnosed with hemophilia A and B.
- •Over 18 years
- •With medical diagnosis of knee arthropathy
- •With clinical evaluation by Hemophilia Joint Health Score
- •In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
- •Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.
排除标准
- •Patients with neurological or cognitive disorders that prevent the understanding of physical tests
- •Not having signed the informed consent document
结局指标
主要结局
Assess the muscle strength
时间窗: Screening visit
The force will be measured with a pressure dynamometer (Lafayette Manual muscle Tester model 01165). This device measures in Newton the force exerted by the patient in the requested muscular action. The higher the value, the greater muscle strength. We will perform the measurements bilaterally. Strength in the quadriceps and triceps surae muscles will be measured. The patient will be asked for 2 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them. In all the measurements, the evaluator will encourage the patient in a standardized way to carry out the contractions. In the measurement of the strength of all the muscles evaluated, the mean value of the measurements obtained will be used as a measure.
次要结局
- Assess the pressure pain threshold(Screening visit)
- Assess the muscle activation(Screening visit)
- Assess the joint status(Screening visit)