Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change from baseline hemarthrosis after treatment and at four weeks.
研究概览
简要总结
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.
Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemophilia A and B
- •Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
- •People over 18 years of age
- •Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
排除标准
- •Patients with neurological or cognitive disorders that impede understanding of the test.
- •Pain free patients
- •Amputees, epileptics or patients with severe vision problems
- •Patients who are receiving Physiotherapy treatment at the time of the study
- •Patients who have not signed the informed consent document
结局指标
主要结局
Change from baseline hemarthrosis after treatment and at four weeks.
时间窗: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee or ankle). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
次要结局
- Change from baseline joint pain after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline muscle strength after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline range of motion after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline joint status after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)