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临床试验/ACTRN12617000644369
ACTRN12617000644369进行中(未招募)未知

The effects of Functional Electrical Stimulation (FES) cycling, recreational cycling and goal-directed training on functional outcomes and participation in children with cerebral palsy - a randomized controlled trial

Ellen Armstrong0 个研究点目标入组 40 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
6 Years 至 18 Years(—)
性别
All

入选标准

  • This study will include children and adolescents with a confirmed diagnosis of CP who at study entry are/have:
  • *Aged 6-18 years;
  • *Classified as functioning at GMFCS levels II, III or IV, as these groups are most likely to have functional goals that align with a STS transfer and cycling intervention;
  • *Goals to improve functional mobility, cycling ability or STS, stepping transfers developed in collaboration with the child, parent and therapist;
  • *Adequate range of motion (ROM) in their hips, knees and ankles to complete a full revolution of the RT300 (cycle ergometer) crank arm;
  • *Able to understand and follow instructions for GMFM-66 testing;
  • *Able to actively engage in up to 45 minutes of physiotherapy;
  • *Able to verbally or non-verbally communicate pain or discomfort;
  • *Able to attend training, testing and follow-up sessions at one of our training facilities.

排除标准

  • Exclusion criteria
  • *Unable to remain in a comfortable position to use the cycling equipment for a period of up to 30 minutes;
  • *Hypersensitivity to touch or unable to tolerate electrical stimulation;
  • *Hip displacement that causes severe pain and would prevent the child from participating in a cycling or sit-to-stand intervention;
  • *Lower limb joint contracture, severe spasticity or severely reduced ROM that could limit the child’s ability to complete a full cycling revolution;
  • *Surgery, trauma or fractures in the preceding 12 months who do not have medical clearance to participate in the 8 week Activate-CP intervention;
  • *Orthopaedic surgery or serial casting scheduled during the study period;
  • *Any contraindication for FES, including cardiac demand pacemakers, pregnancy or skin damage that may interfere with electrode placement;
  • *Any children with known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the 8 week cycling intervention;
  • *Uncontrolled seizures or epilepsy.

研究者

发起方
Ellen Armstrong

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