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临床试验/NCT03531164
NCT03531164招募中不适用

Effect of Kayak Ergometer Training in Trunk Control, Independence and Cardiovascular Health in Individuals With Spinal Cord Injury

Instituto Nacional de Rehabilitacion1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
1
主要终点
Trunk control

研究概览

简要总结

One of the main objectives in spinal cord injury rehabilitation programs is the improvement of trunk control in order to achieve independence, to prevent complications and, in specific cases to walk.

Research question: What is the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury? Purpose: To determine the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury.

Methods: Randomized clinical trial, blinded to evaluator and to the person that will analyze data.

Population: Spinal cord injured individuals treated at the National Institute of Rehabilitation, with a spinal cord injury of any ethiology, with a neurologic level of C8 and below, with time since injury from three months to one year.

Proceeding: The subjects will be randomly assigned to : a control group with neuro propioceptive facilitation exercises focused in trunk control or an experimental group with kayak ergometer training. Both groups will recieve 5 sessions a week during 6 weeks.

详细描述

Spinal Cord Injury (SCI) is an alteration of the spinal cord that modifies not only muscular strength and sensitivity, but that also generates a change in all of the systems of the organism. At the worldwide level, an incidence is calculated of between 13.1 and 52.2 per one million inhabitants.

Damage to the ascending and descending tracts of the spinal cord consequently gives rise to an alteration in the postural control system. It is known that effective postural control is of utmost importance forstanding and walking, as well as for providing support for voluntary movements. Alterations in posture depend on the grade and level of the injury; thus, persons with complete, thoracic, or cervical lesions have poor trunk control. Due to the latter, they are limited in many of the movements necessary for carrying out daily life activities (DALYS) Therefore, part of the objectives of rehabilitation in individuals with an SCI comprises improvement in trunk control.

On the other hand, patients with SCI tend to engage in a sedentary lifestyle that, added to the alterations in the autonomic nervous system proper to the lesion, exposes individuals with a SCI to a greater risk of developing chronic-degenerative conditions, such as metabolic syndrome and cardiovascular diseases, which are, at present, the main cause of death in these persons.

Thus, after the immediate rehabilitation, it is necessary to maintain and improve the functional capacity obtained during this process. Therefore, it is important to find training activities to challenge stabilization of the upper part of the body and sitting equilibrium without giving rise to symptoms caused by overuse.

Kayak training appears to comply with these criteria, in that it implicates the greater part of the upper musculature, presents high metabolic demands, and imposes strict requirements for the balance control system, due to continuous compensation of the disturbances of the upper part of the body caused by movement on the apparatus. It was previously demonstrated that open-sea training in kayaks could be implemented in a group of individuals in paraplegic condition and that this is accompanied by improvements in strength and equilibrium in sedestatIon.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of spinal cord injury with any American Spinal Injury Association Impairment Scale (AIS) classification
  • Neurologic level below C8
  • Time since injury form 3 to 12 months
  • Any aetiology

排除标准

  • Another neurologic diagnosis
  • Sense organ alteration
  • Orthopaedic problem that interferes with training
  • Alteration in superior mental function
  • Cardiovascular or metabolic disease that interferes with trainig

结局指标

主要结局

Trunk control

时间窗: 6 weeks

Score between 0-24, cut-off point 13. Higher values represent better results. The clinical trunk control test for individuals with spinal cord injury will be used

次要结局

  • Arterial tension(6 weeks)
  • Satisfaction with life(6 weeks)
  • Cardiac frequency(6 weeks)
  • Metabolic Equivalent of Task(6 weeks)
  • Oxygen consumption(6 weeks)
  • Spinal Cord Injury Independence Measure III(6 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jimena Quinzaños

MD, MSc

Instituto Nacional de Rehabilitacion

研究点 (1)

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