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临床试验/NCT03914287
NCT03914287已完成不适用

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.

Investigación en Hemofilia y Fisioterapia2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年2月2日最近更新:
适应症

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

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)

研究者

发起方
Investigación en Hemofilia y Fisioterapia
申办方类型
Network
责任方
Sponsor

研究点 (2)

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