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临床试验/NCT04309903
NCT04309903已完成不适用

The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia

Necmettin Erbakan University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年7月12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
17
试验地点
2
主要终点
Hemophilia Joint Health Score

研究概览

简要总结

Uncertainty about how to treat existing hemophilic arthropathy (HA) is the most important issue that will increase functionality and joint health. Recent studies have shown that MT can be used safely for improving joint health, pain and ROM with no bleedings in PwH with elbow and ankle HA. Unlike MT studies in hemophilia, we investigated the effects of MT on important parameters such as muscle strength (MS), functional level, joint health, functional independence score in hemophilia (FISH) and kinesiophobia. These parameters are closely related to functional level and quality of life of PwH. Therefore, evaluation of these parameters and determining the effects of the MT on these parameters are very important for both PwH and also clinicians.

详细描述

The aim of this study was to investigate the effects of manual therapy in addition to home exercise program on hemophilia functional independence level, joint health, kinesiophobia, functional level, range of motion, muscle strength and pain level in hemophilic individuals with lower extremity joint arthropathy. Hemophilic arthropathy was developed in at least one of the lower extremity joints and aged between 18-30 years 17 severe type hemophilic men were participated in the study. The participants were divided into two groups as Home Exercise Group (HEG) and Manual Therapy Group (MTG) by randomization method. While the HEG was performed the exercise program at home, in addition to the same HEG manual therapy were applied to the MTG by the same physiotherapist 3 days a week for 1 hour. Both groups were followed for a total of 5 weeks and pre-treatment evaluations were repeated post-treatment. The joint health of the hemophilics in both groups were evaluated with Hemophilia Joint Health Score (HJHS), their kinesiophobia level were evaluated with Tampa Kinesophobia Scale, their functionality with the Functional Independence Score in Hemophilia (FISH). In addition, Functional Reach, Timed Up and Go and 5 Times Sit-to- Stand tests were used for functional level. The range of motion was evaluated with a goniometer, muscle strength was measured with a digital dynamometer and pain level was assessed with a Visual Analogue Scale (VAS). Number of hemarthrosis decreased in both groups.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with hemophilia who have arthropathy developed in any of the lower extremity joints due to severe hemophilia and to be receiving regular prophylaxis (3*1500 IU/ per week), but not having regular physical activity and sports.

排除标准

  • Patients with hemophilia who had any disease related to connective tissue, any surgery that affects lower limb function (joint debridement, fracture, prosthesis), any neurological disease or cognitive impairment that may affect functional level, any sensorial loss of peripheral nerve injury and did not attend their sessions and evaluations regularly.

结局指标

主要结局

Hemophilia Joint Health Score

时间窗: 5 week

We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health

Functional Independence Score in Hemophilia

时间窗: 5 week

We used the functional independence of patients. Score ranged from 0 to 32. High score indicates the functional independence.

Tampa Kinesiophobia Scale

时间窗: 5 week

Score higher than 37 were associated with a high degree of kinesiophobia.

次要结局

  • Range of motion(5 week)
  • Muscle Strength(5 week)
  • Numerical Pain Scale(5 week)
  • Frequency bleeding(5 week)
  • Functional Reach(5 week)
  • Timed Up and Go(5 week)
  • 5 Times Sit to Stand(5 week)

研究者

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

Necati Muhammed TAT

Lecturer

Necmettin Erbakan University

研究点 (2)

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