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临床试验/NCT05947110
NCT05947110已完成不适用

How Effective is the Plyometric-based Hydro-kinesio Therapy for Pain, Muscle Strength, Postural Control, and Functional Performance in Children With Hemophilic Knee Arthropathy?

Cairo University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年9月5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
48
试验地点
1
主要终点
Postural control

研究概览

简要总结

This study was designed to assess the effect of an 8-week plyometric-based hydro-kinesio therapy (Plyo-HKT) on pain, muscle strength, postural control, and functional performance in a convenience sample of children with hemophilic knee arthropathy (HKA). Forty-eight patients with HKA were randomly allocated to the Plyo-HKT group (n = 24, received the plyometric-based hydro-kinesio therapy program, twice/week, over 8 weeks) or the control group (n = 24, received standard exercise program). Both groups were assessed for pain, muscle strength, postural control, and functional performance pre and post-treatment.

详细描述

Forty-eight boys with moderate hemophilia-A were recruited from the hematology clinics of three large referral hospitals in Riyadh, Saudi Arabia. The study included patients who were 8-16 years old, had factor VIII replacement prophylaxis, were clinically-stable cases, had unilateral knee hemarthrosis, had grade II or III knee arthropathy, had muscle strength of grade three, and if they were able to walk independently. Patients who had enduring disabling pain, fixed deformities, a history of musculoskeletal surgery, visual and/or vestibular deficits, or bleeding episodes within two weeks before enrollment were excluded.

Outcome measures

Pain: Pain during rest and/or movement was assessed using the Numerical Pain Rating Scale.

Muscle strength: The peak concentric torque of the quadriceps and hamstring muscles was measured through an Isokinetic Dynamometer.

Postural control: The directional dynamic limit of stability (forward, backward, affected, and non-affected) and overall limit of stability were assessed using the Biodex balance system.

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)

盲法说明

This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Eight and 16 years.
  • Had factor VIII replacement prophylaxis.
  • Clinically-stable.
  • Unilateral knee involvement.
  • Knee arthropathy of grade II or III per the Arnold-Hilgartner radiographic classification.
  • Muscle strength of grade 3 in lower limb muscles.
  • Use of no pain medication for one month prior to enrollment.
  • Walking independently.

排除标准

  • Enduring disabling pain
  • Fixed deformities.
  • History of musculoskeletal surgery.
  • Visual or vestibular deficits.
  • Engagement in regular exercises.
  • Bleeding episodes within two weeks prior to enrolment.

结局指标

主要结局

Postural control

时间窗: 2 months

The capacity to control and move the center of gravity in various directions across the base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.

Pain intensity

时间窗: 2 months

Participants reported how much they feel pain during rest and/or movement on the 0-10 Numerical Pain Rating Scale, where 0 represents "no pain" and 10 indicates the "worst possible pain".

Muscle strength

时间窗: 2 months

Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.

次要结局

  • Functional independence(2 months)
  • Six-minute walk test(2 months)

研究者

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

Ragab Kamal Elnaggar

Associate Professor

Cairo University

研究点 (1)

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