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.
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