Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Bleeding frequency
研究概览
简要总结
Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.
Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created.
Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia.
Describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment.
Report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.
详细描述
Phase I pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose.
Phase II. Randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.
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
- 否
入选标准
- •Patients with a diagnosis of hemophilia A and B.
- •Patients older than 18 years.
- •Patients with a diagnosis of hemophilic arthropathy of the knee and ankle.
- •Patients on prophylactic regimen with FVIII / FIX.
排除标准
- •Patients without walking ability.
- •Patients with a diagnosis of other congenital coagulopathy (eg von Willebrand disease).
- •Patients who have developed antibodies to FVIII / FIX (inhibitors).
- •Patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test.
- •Patients who have not signed the informed consent document.
结局指标
主要结局
Bleeding frequency
时间窗: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from number of bleeding during treatment and follow-up period at 1 month
次要结局
- Joint function(Screening visit, within the first seven days after treatment and after one month follow-up visit)
- Pain(Screening visit, within the first seven days after treatment and after one month follow-up visit)
- Range of motion(Screening visit, within the first seven days after treatment and after one month follow-up visit)
研究者
Rubén Cuesta-Barriuso, PhD
PhD
Universidad Católica San Antonio de Murcia