ACTRN12611001079932已完成未知
Functional electrical stimulation (FES)-assisted cycling versus passive cycling following spinal cord injury: Change in muscle cross-sectional are of thigh and calf post-intervention compared with baseline post spinal cord injury.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants will be included if they:
- •a)Have sustained a complete (AIS A) or incomplete SCI (AIS B, C) above T12 no more than 3 weeks previously
- •b)Have undergone internal fixation of spinal fracture or whose fracture is considered sufficiently stable
- •c)Are medically stable
- •d)Are able to provide informed consent
- •e)Have medical and surgical clearance to participate in the study
排除标准
- •Participants will be excluded if they:
- •a)Are under 18 years of age
- •b)Are classified as AIS D at baseline
- •c)Are in a halo or receiving any other traction
- •d)Are in ICU
- •e)Have pressure ulcers
- •f)Have peripheral nerve lesion
- •g)Have long bone or pelvic fracture
- •h)Have lower limb amputation
- •i)Have had previous FES to lower limbs
- •j)Are on a ventolator
- •k)Have metabolic bone disease, including lytic or renal bone disease, or senile osteoporosis
- •l)Have had exposure to drugs that affect bone metabolism (amino-bisphosphonate, high dose glucocorticoids, cyclosporine, anti-epileptic drugs [AEDs])
- •m)Have any contraindications to FES or MRI (cardiac pacemaker, epilepsy, pregnancy, skin grafts, lower limb injuries)
- •n)Have any other contraindications to participating in exercise programs, or outcome assessments, as advised by the treating physician (e.g. autonomic hyper-reflexia, suboptimal oxygen saturation)
- •o)English language competency insufficient to understand research procedures and provide informed consent.
- •p)Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the Protocol.
- •q)Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.
研究者
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