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临床试验/NCT05125666
NCT05125666Unknown2 期

Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
30
试验地点
1
主要终点
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.

研究概览

简要总结

The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).

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
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children with the following criteria will be in rolled in the study
  • Age range from (5-10 years).
  • Severity of ataxia will be from 15-30 by SARA scale.
  • Children after 2 months of medulloblastoma resection.
  • They can stand and walk with minimal support.
  • They have good cognition, compliance, and ability to understand and instructions.
  • Children receiving radiotherapy and chemotherapy sessions
  • They are medically stable

排除标准

  • Children will be excluded from the study if they have
  • Any neuromuscular disorder.
  • Visual impairment.
  • Cognitive problem
  • Convulsion.
  • Peripheral neuropathy due to chemotherapy.

结局指标

主要结局

Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.

时间窗: 2 months

Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.

时间窗: 2 months

Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.

时间窗: 2 months

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

Fatma Mostafa Sedeek Selim

Professor

Cairo University

研究点 (1)

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