ACTRN12620001241921招募中未知
To investigate transcutaneous spinal cord stimulation combined with locomotor training on walking ability in people with chronic spinal cord injury: a multi-centre double-blinded randomised sham-controlled trial
euroscience Research Australia0 个研究点目标入组 50 人开始时间: 2020年11月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 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
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •A person will be eligible to participate if they:
- •have a SCI sustained a minimum of 12 months prior to consent
- •have bilateral motor levels between T1 and T11
- •have a Walking Index for Spinal Cord Injury II (WISCI II) between Level 1 and 6*
- •have a reproducible, voluntary muscle flicker/contraction in at least one muscle that flexes or extends the hip, knee, ankle or big toe, on either side of the body
- •are willing and able to participate in the stimulation/locomotor training program 3 times a week for 12 weeks, including one follow-up visit at 16 weeks
- •are aged 16 years or over at the time of consent and able to give informed consent
- •are considered by their spinal specialist to be medically stable to undertake the program (including clearance for standing/locomotor training)
- •*1 = Ambulates in parallel bars, with braces and physical assistance of two persons, but less than 10 metres
- •6 = Ambulates with walker, with braces and physical assistance of one person, 10 metres
排除标准
- •A person will be ineligible to participate if they:
- •have a history of clinically significant autonomic dysreflexia in response to electrical stimulation
- •cannot tolerate transcutaneous spinal stimulation at a therapeutic intensity
- •have a history of hypotension in response to prolonged standing
- •have a progressive neurological disease and any other major neurological lesion additional to the spinal cord injury, e.g., a severe traumatic brain injury or stroke
- •have a history of long-bone fracture, family history of fragility fracture or any disorders of the bone, such as Paget’s disease
- •have a syringomyelia (syrinx) on recent MRI. Radiological findings such as myelomalacia which have been evaluated by a neurosurgeon as non-progressive may still be eligible
- •have had open surgery within the last 3 months
- •unable to elicit reflexes whilst experiencing the stimulation suggesting a lower motor neurone lesion
- •have severe lower limb spasticity (MAS = 4 in any lower limb muscle)
- •have extensive lower limb contractures preventing ambulation
- •have any serious medical condition, cognitive impairment, drug dependency, psychiatric illness or behavioural problem preventing them from adhering to the protocol
- •have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
- •have a previous pressure ulcer treated with a myocutaneous flap using a graft from a locomotor muscle such as the gluteal or hamstring
- •have any contraindications to electrical spine stimulation such as cardiac pacemaker, lower limb fracture, baclofen pump, pregnancy, or implanted electronic devices
- •have an upper limb injury preventing prolonged weight bearing through their arms
- •have had stem cell or olfactory ensheathing cell therapy within the last 5 years
- •are actively participating, or are in the follow-up period, of any other clinical trials
研究者
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