Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test
研究概览
简要总结
This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.
The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with paraplegia, ageb between 18 and 45 years
- •Body mass index (BMI) between 18.5 and 29.9
- •2 to 15 years after the accident, ASIA A or B, lesion situated between T3 and T12
- •Medically stable
- •Able to follow instructions
- •Persons who have provided written informed consent
排除标准
- •Persons without national health insurance cover
- •Arterial blood pressure > 140/90 mmHg, arrythmia, heart disease, diabetes, impaired kidney function, cancer
- •smoking-induced intoxication,
- •Medical treatment for cardiovascular disease or antidepressants
- •Orthostatic hypotension with a symptomatic fall in arterial pressure > 30 mmHg in the vertical position
- •Grade 2 or more pressure sores
- •Other associated neurological diseases (e.g. cerebrovascular accident, peripheral neuropathy, myopathy)
- •Any disease affecting the shoulder that may compromise the ability to use the rowing machine.
- •Coagulation disorders;
- •Presence of an implanted electronic device
研究组 & 干预措施
Paraplegic patients
干预措施: strengthening (Other)
Paraplegic patients
干预措施: hybrid training programme (Other)
结局指标
主要结局
Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test
时间窗: Change from baseline in VO2max at 9 months
次要结局
未报告次要终点