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.
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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