Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline ankle bleeding after treatment and at 3 months
研究概览
简要总结
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.
Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.
Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The physiotherapist in charge of the evaluations was blinded to the conditions and study objectives.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years old
- •Patients with a medical diagnosis of hemophilia A or B.
- •Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- •Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- •Nno scheduled orthopedic surgeries during the study phase.
- •Signing the informed consent document.
排除标准
- •Patients with ankle hemarthrosis in the month before the beginning of the study.
- •Patients unable to walk even with technical aids.
- •Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.
- •Patients failing to complete at least 80% of the sessions scheduled in the intervention
结局指标
主要结局
Change from baseline ankle bleeding after treatment and at 3 months
时间窗: Screening visit, within the first seven days after treatment and after three months follow-up visit
The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.
次要结局
- Change from baseline range of ankle motion after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline ankle pain after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline functional capacity after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)