Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Change from baseline joint pain of ankle after treatment and at 5 months
研究概览
简要总结
Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition.
At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.
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 —（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
- •Adults patients
- •Patients with hemophilic arthropathy of ankle diagnosed
- •Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.
排除标准
- •Patients without ambulation
- •Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease)
- •Patients who have developed antibodies to FVIII / FIX (inhibitors)
- •Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical
- •Patients that have not signed the informed consent document.
研究组 & 干预措施
Experimental group
Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each.
The treatment program includes 8 maneuvers that must be administered bilaterally: maneuver longitudinal sliding on the fascial surface plant, maneuver induction of the plantar fascia, maneuver longitudinal surface sliding on the anterolateral compartment of the leg, induction maneuver ankle anterior compartment, maneuver pressure and sliding on the posterior region of the leg, technical release of the popliteal fascia, maneuver induction sural triceps, and lower extremity telescopic technique.
干预措施: Physiotherapy sessions (Other)
Control group
Patients included in this group will not receive any physiotherapy treatment. However, will be evaluated under the same conditions that patients in the experimental group (pretreatment evaluation, post-treatment and follow-up).
结局指标
主要结局
Change from baseline joint pain of ankle after treatment and at 5 months
时间窗: Screening visit, within the first seven days after treatment and after five months follow-up visit
Change from joint pain of ankle during treatment and follow-up period at 5 months. The perception of ankle pain will be measured using visual analog scale (scale 0-10).
Change from baseline range of motion after treatment and at 5 months
时间窗: Screening visit, within the first seven days after treatment and after five months follow-up visit
Change from range of movement of ankle and knee during treatment and follow-up period at 5 months. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia
Change from baseline bleeding frequency after treatment and at 5 months
时间窗: Screening visit, within the first seven days after treatment and after five months follow-up visit
Evaluation of the frequency of muscle and joint bleeds through registration. The frequency of bleeding of the ankle joint is measured with a registry given to patients at the beginning of the study.
Change from baseline joint function after treatment and at 5 months
时间窗: Screening visit, within the first seven days after treatment and after five months follow-up visit
Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
次要结局
- Height(Screening visit)
- Weight(Screening visit)
- Age(Screening visit)