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临床试验/ACTRN12609000695202
ACTRN12609000695202已完成未知

Early Intensive Hand Rehabilitation After Spinal Cord Injury: Effect of a novel muscle-stimulator device versus standard treatment on hand function in participants with spinal cord injury.

The University of Melbourne0 个研究点目标入组 78 人开始时间: 2009年8月12日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
78

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
16 Years 至 o limit(—)
性别
All

入选标准

  • * have sustained a Spinal Cord Injury (SCI)within the preceding 6 months from time of consent
  • * are currently receiving inpatient rehabilitation through one of the study sites
  • * will remain in hospital for 12 weeks after initial screening
  • * are 16 years of age or older and able to provide informed consent
  • * have a motor complete or incomplete spinal cord injury at the neurological level of C2 to T1 (as per the International Standardised Neurological Assessment for SCI)
  • * can actively flex their target shoulder to 60 degrees
  • * have reduced ability to grasp using the target hand
  • * are able to tolerate sufficient Functional Electrical Stimulation (FES) to enable one hand to grasp and release
  • * have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist

排除标准

  • * have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries)
  • * have had recent trauma or surgery to the target hand or upper limb within the last 12 months
  • * have had amputation of any digits on the target hand
  • * are not able to sit out of bed each day for at least 2 hours over three consecutive days
  • * have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce
  • * have severe spasticity in the target hand or upper limb preventing use of the ReJoyce
  • * are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit
  • * are likely to undergo hand surgery in the target hand in the next year
  • * are likely to experience autonomic dysreflexia and/or hypotension in response to electrical stimulation
  • * have any contraindications to FES such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy
  • * have intracranial metal implants
  • * have impaired vision and/or are unable to view a computer screen
  • * 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 the participant from adhering to the Protocol.

研究者

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