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临床试验/NCT02193386
NCT02193386已完成不适用

Evidence-based Practice and Its Effectiveness in Physical Therapy Treatment of Children With Bilateral Spastic Cerebral Palsy.

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in Gross Motor Function Measure - 88

研究概览

简要总结

The study aims to evaluate evidence-based practice behavior in usual care physical therapy in Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy program based on evidence-based guidelines to the effects of a period of usual care. It is hypothesized that supporting therapists by providing a predefined evidence-based intervention program, will result in an improved treatment outcome compared to the usual care physical therapy.

详细描述

Participants A convenience sample of 16 children will be recruited at the Cerebral Reference Centre of the University Hospital Pellenberg. Children will be included when they are diagnosed with bilateral spastic CP, aged between 4 and 9 years and a Gross Motor Function level between I and III. Children are excluded when they received Botulinum Toxin A injections within the past six months, orthopedic surgery in the past or had severe associated problems that limited participation to therapy (blindness, deafness, severe cognitive limitations or autism).

Design All children will start the study with a registration period. During this period, the children's usual physical therapy (UC) will be registered using a diary. Immediately following the UC period, children will be enrolled into a predefined intervention program (IP).

Both the period of UC and IP will have a duration of 10 weeks. Before and after both periods, children will be evaluated using the Gross Motor Function Measurement (GMFM-88) and three-dimensional gait analysis (3DGA).

Therapy interventions During the period of UC, no specific intervention will be provided. Children will receive the frequency, intensity and contents of therapy as they usually receive by their own private physical therapist. A diary will be provided to the child's physical therapist. The diary contains session forms, designed for the therapist to carefully register the contents of therapy after each session.

In the session forms, the therapist will note down how much time of the therapy session will target problems at the different levels of the ICF. At the level of body structure and function, the time spent on muscle length and muscle strength will be registered. For muscle length, the therapists are asked to report the targeted muscles, the number of repetitions, the duration of stretch and treatment modality (activo, activopassivo or passivo). About muscle strength, therapists will note the specific muscle that was trained, the intensity (number of repetitions and resistance) and whether the exercise was performed as analytical (single-joint) or functional (multiple-joint) muscle work. Concerning activity level, the specific functional activity that was practiced and the averaged position in which this was performed, will be registered. Finally, the therapist will be asked to report whether any problems at participation level are specifically addressed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cerebral Palsy
  • Age 4- 9 y
  • Gross Motor Function Classification I-III (ambulant)

排除标准

  • Severe associated problems limiting participation to the programs
  • Severe musculoskeletal limitations

结局指标

主要结局

Change in Gross Motor Function Measure - 88

时间窗: baseline, after 10 weeks of usual care and after 10 weeks of intervention

次要结局

  • Change in three-dimensional gait analysis(baseline, after 10 weeks of usual care and after 10 weeks intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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