ACTRN12621000679886已完成未知
Intensive long-term rehabilitation for people livingwith chronic spinal cord injury: a feasibility trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 5
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion/exclusion criteria for participants have been determined in consultation with medical and
- •rehabilitation specialists including a clinician with a lived experience of SCI.
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •i. Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent
- •and have completed their primary rehabilitation;
- •ii. Have stable neurological level and functional ability of more than 6 months in duration;
- •iii. Are over 18 years and able to give informed consent;
- •iv. Are ASIA A or B (as per the International Standards for Neurological Classification of
- •v. Are able and willing to attend an exercise program five times per week for 26 (16 weeks 'on-site' and 10 weeks 'at-home') weeks;
- •vi. Are considered by their general practitioner or specialist medical consultant to be fit to
- •undertake the exercise program (documented approval by general practitioner or
- •specialist medical consultant required).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •i. Have significant concomitant central nervous system, peripheral nervous system or
- •musculoskeletal system injuries or disorders limiting ability to exercise;
- •ii. Have had recent major trauma or surgery within the last 6 months;
- •iii. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer
- •Advisory Panel classification;
- •iv. Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic
- •or renal bone disease, and senile osteoporosis;
- •v. Have a medical history of exposure to medication(s) known to affect mineral or bone
- •metabolism;
- •vi. Have significant impairment or disability, including physical, neurological or
- •psychological impairments, additional to the spinal cord injury;
- •vii. Have a history of long bone fracture incompletely healed;
- •viii. Have extensive fixed contractures in the upper or lower limbs;
- •ix. Have severe spasticity;
- •x. Have uncontrolled neuropathic pain;
- •xi. Have autonomic dysreflexia without a management plan;
- •xii. Are unable to attend the 2-week pre-assessment and the 8-week follow-up
- •assessments;
- •xiii. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb
- •fracture or pregnancy;
- •xiv. Have any other serious medical condition including malignancies, psychiatric,
- •behavioral 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;
- •xv. Have symptomatic, radiologically demonstrated, or provocatively demonstrated
- •ischaemic heart disease;
- •xvi. Have current thromboembolic disease;
- •xvii. Are using illicit drugs;
- •xviii. Are participating in other clinical trials (including medication, therapeutic
- •interventions and alternative therapies) or taking medications (including herbal
- •preparations) that are not considered to be standard care as per the protocol;
- •xix. Are unable to tolerate expected exercise load.
研究者
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