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
- 58
- 试验地点
- 2
- 主要终点
- Change from baseline ankle joint pain 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
- 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 disease.
- •Over 18 years.
- •Diagnosed with hemophilic arthropathy of the ankle (by clinical assessment with the Hemophilia Joint Health Score).
- •On prophylactic or on demand treatment with FVIII / FIX concentrates.
排除标准
- •Patients without ambulation ability.
- •Patients with inhibitors (antibodies to FVIII or FIX).
- •Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests.
- •Not signed the informed consent document.
结局指标
主要结局
Change from baseline ankle joint pain 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
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
次要结局
- Change from baseline ankle joint 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 lower limb functionality 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 range of motion of ankle 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 muscle strength 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 muscle flexibility after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
