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临床试验/NCT06438406
NCT06438406已完成不适用

Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy

University of Palermo2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
prevention of haemophilic arthropathy

研究概览

简要总结

Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows.

The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.

We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.

The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.

All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).

Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient's quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient's alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 50 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • diagnosis of severe haemophilia A or B;
  • age ≥ 6 years and ≤ 50 years;
  • presence of hindfoot and/or arch misalignment;
  • prophylaxis with factor deficient (VIII or IX).

排除标准

  • patients with prosthetic implants/synthetic means
  • uncooperative patients

结局指标

主要结局

prevention of haemophilic arthropathy

时间窗: All patients were assessed at 3 months (T1) and after 6 months (T2).

During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination

次要结局

  • Numerical Rating Scale (NRS)(All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2))
  • Functional Independence Score in Hemophilia (FISH)(All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2))
  • Hemophilia Joint Health Score (HJHS)(All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

研究点 (2)

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