ACTRN12610000498099已完成未知
Intensive Exercise Program After Spinal Cord Injury: Effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement in people at least 6 months post spinal cord injury
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 188
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:
- •1. Have sustained a traumatic spinal cord injury (SCI) a minimum of 6 months prior to consent and have completed their primary rehabilitation
- •2. Are 18 years or older and able to give informed consent
- •3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
- •4. Are able and willing to attend an exercise program 3 times per week for 12 weeks
- •5. Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by the medical consultant is required).
排除标准
- •Participants will not be included if they:
- •1. Have brachial plexus, cauda equina, or peripheral nerve injury
- •2. Have had recent major trauma or surgery within the last 6 months
- •3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
- •4. Are post-menopausal at time of injury (females)
- •5. Have Body Mass Index (BMI) at injury falling below lower threshold of healthy adult reference range
- •6. Have endocrinopathy or metabolic disorders of bone, such as Paget’s disease, lytic or renal bone disease and senile osteoporosis
- •7. have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
- •8. Have chronic systemic diseases, e.g. Hepatitis C (Hep C), Human Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDs)
- •9. Have significant impairment or disability, including physical, neurological or psychological impairments
- •10. Have a history of long bone fracture, or family history of fragility fracture
- •11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
- •12. Have extensive fixed contractures in upper or lower limbs
- •13. Have severe spasticity
- •14. Have uncontrolled neuropathic pain
- •15. Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
- •16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
- •17. Have any contraindications to Functional Electrical Stimulation (FES) such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
- •18. Have intracranial metal implants (for Transcranial Magnetic Stimulation (TMS) only)
- •19. 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.
- •20. 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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