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临床试验/NCT05956444
NCT05956444已完成不适用

Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy

Pamukkale University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Pediatric Balance Scale (PBS)

研究概览

简要总结

Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Aim of this study was to investigate the effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute to the literature on this subject. Cases were randomized into study and control groups. At the beginning of the study, the balance skills of all the cases with spastic cerebral palsy were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific, neurodevelopmental therapy program with intensive gait and balance training was applied to the study group in a 45-minute single session, 2 days a week. The control group received 8 weeks of conventional physiotherapy. At the end of the treatment process, the evaluations were repeated with the same methods.

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
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Cerebral Palsy diagnosis
  • •Spastic type
  • •Gross Motor Function Classification System Level I and II

排除标准

  • •Tendon release surgery or Botox application in the last 6 months

研究组 & 干预措施

Treatment Group

Experimental

Treated with both the treatment programs determined on the basis of the NDT and conventional physiotherapy. Programs prepared specifically for each child, in a 45-minute single session, 2 days a week, for 8 weeks in total. Each child was given a treatment program tailored to their needs.

干预措施: Neurodevelopmental Therapy (NDT) (Other)

Treatment Group

Experimental

Treated with both the treatment programs determined on the basis of the NDT and conventional physiotherapy. Programs prepared specifically for each child, in a 45-minute single session, 2 days a week, for 8 weeks in total. Each child was given a treatment program tailored to their needs.

干预措施: Conventional Physiotherapy (Other)

Control Group

Active Comparator

Treated with only the treatment programs determined on the basis of conventional physiotherapy.

干预措施: Conventional Physiotherapy (Other)

结局指标

主要结局

Pediatric Balance Scale (PBS)

时间窗: 8 weeks

Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.

LEGSys, Temporospatial Gait Analysis Device

时间窗: 8 weeks

Determining the patient's risk of falling by performing a kinetic analysis of the gait

LEGSys, Temporospatial Gait Analysis Device

时间窗: Beginning of the study

Determining the patient's risk of falling by performing a kinetic analysis of the gait

Pediatric Balance Scale (PBS)

时间窗: Beginning of the study

Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.

次要结局

未报告次要终点

研究者

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

Fatih Tekin

Assist. Prof.

Pamukkale University

研究点 (1)

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