Comparative Study of Working With the LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation and Improvement of Quality of Life in Adult Stroke Patients. Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- quality of life scale
研究概览
简要总结
The use of robotic technology for the treatment of gait in neurological pathologies has provided different results in scientific evidence. In patients with some types of acquired brain damage, such as stroke, the use of Lokomat® therapy can bring improvements in aspects such as gait speed and balance, among other parameters and report greater functional recovery in subacute patients with greater deterioration. Similarly, the use of another technological element such as the C-Mill® reports improvements in various aspects of ambulation and balance in gait treatments for stroke patients. Likewise, the impact on the person's recovery is not only beneficial for gait rehabilitation, but also improves the perception of well-being, which can be positive in the process of readaptation to daily life.
The effect of both treatments for gait rehabilitation in adults with stroke and their impact on quality of life in the neurorehabilitation clinic will be studied.
adults with stroke and their impact on quality of life at the Lescer neurorehabilitation clinic Lescer, Madrid (Spain). Participants will be assessed at baseline, 4 weeks, 8 weeks and 12 weeks.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. .
- •Subjects who are cognitively capable and who sign the informed consent form.
排除标准
- •Severe cognitive impairment (Mini-Mental State Examination < 24.), or impairment that prevents correct understanding of the correct understanding of the messages and explanatory orders of the treatment and its conditions.
- •Diagnosis of concomitant neurological diseases and craniocerebral trauma. cranioencephalic trauma.
- •Other diseases that interfere with the gait process (e.g. disabling arthritis or arthrosis, other neurological diseases, other neurological diseases).
- •disabling arthritis or osteoarthritis, other concomitant neurological diseases, etc.).
- •- Contraindications of the robotic tools themselves.
研究组 & 干预措施
Lokomat
To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs.
stroke with the Lokomat® tool.
干预措施: Lokomat® (Device)
C-Mill
Exoelectric walking aid for patients who have suffered a stroke
干预措施: C-Mill (Device)
结局指标
主要结局
quality of life scale
时间窗: 12 weeks
QoL39 scale. 0 minimum - 100 maximum (higher scores mean a better outcome).
Spasticity index
时间窗: 12 weeks
Tardieu scale 0 min - 5 max (higher scores mean a worse outcome).
次要结局
未报告次要终点
研究者
Jorge Velazquez
PhD. Physiotherapy
Universidad Pontificia de Salamanca