跳至主要内容
临床试验/NCT01864382
NCT01864382已完成不适用

Effects of the Inclusion of Exercises "Core Stability" in the Treatment of Inpatient Physiotherapy to Improve Balance in Post-stroke Patients Sitting in Subacute Phase. Randomized Clinical Trial.

Rosa Cabanas Valdés4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
4
主要终点
Dynamic sitting balance

研究概览

简要总结

The stroke as cerebrovascular disease is the leading cause of permanent neurological disability and the third death in the Western world. Their affected often have motor and sensory disturbances in the form of hemiparesis with a possible influence on the balance be altered trunk muscles, important components of postural control. The treatment of stroke, covers a wide range of different strategies and approaches physiotherapy, including, specific exercises on the trunk called "core stability", performed by the patient with the help and supervision of a physiotherapist specializing in neurology, that are based on coordination, motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness of these last years has been demonstrated empirically, but until now there is no sufficient evidence of the effects of these exercises on sitting balance in respect, and standing up in the subacute phase post-stroke patients. To prove the evidence raises a randomized, multicenter, blinded and where the evaluator will not participate in the analysis and processing is done by intention to treat. Patients will be divided into two groups: control (usual physiotherapy center made ) and experimental (made also 15 minutes workout "core stability"). The intervention will have a frequency of 5 days a week for 5 weeks and up to 12 weeks. The expected effect is that the experimental group patients develop better postural control at the trunk and this influences the balance in sitting, standing and walking.

详细描述

The deterioration in the balance sitting and poor sitting ability, clinical problems are common after stroke. These patients show a significant decrease in the performance level of the trunk, compared to healthy individuals of the same age and sex and present asymmetry of the trunk and pelvis.

Sitting involves the ability to achieve a variety of objects that are in and out of arm's length, as personal daily activities, showering, going to the bathroom and dressing. These arm movements, triggering postural adjustments in the muscles of the trunk and lower extremities, which anticipated the movement always precede the active movement. This anticipative control can be altered in subjects with stroke.

The trunk seems particularly important for balance, as stabilizes the pelvis and spine. Dean et al, (1997; 2007) and Ibrahimi (2010) showed a beneficial effect on functional scope of practice tasks, sitting in variables dynamic sitting balance, load weight of the affected side and standing. Also in the studies of Howe (2005); Verheyden (2009); Saeys (2011);Karthikbabu (2011) and Kumar (2011) with specific exercises for the trunk, favorable outcomes were obtained compared with standard treatment. However, these studies with few patients and without any monitoring, it needs to be confirmed (what is this study intended)

研究设计

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

入排标准

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

入选标准

  • Adults of either sex
  • > 18 years with a diagnosis of stroke, ischemic or hemorrhagic origin <3 months of evolution
  • Orthopedic problems not present to keep sitting. Ability to understand instructions
  • The Index Barthel ˂ 70 points and Trunk Impairment Scale ˂ 16 points.

排除标准

  • Patients with cognitive problems, Mini mental state examination ˂ 24
  • Patients with a second stroke confirmed by Neurology services or previous motor disability that altered the balance, or a Rankin value not superior to 3
  • The patients with stroke hemorrhagic origin with surgical treatment.

结局指标

主要结局

Dynamic sitting balance

时间窗: Baseline, up to 25 sessions and follow up to 24 weeks

Trunk Impairment Scales:Is a tool to measure the motor impairment of the trunk after stroke, This scale evaluates dynamic sitting balance as well as co-ordination of trunk movement.

次要结局

  • Standing balance(Baseline, up to 25 sessions and follow up to 24 weeks)

研究者

发起方
Rosa Cabanas Valdés
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rosa Cabanas Valdés

Instructor of the Physical Therapy teaching staff

Universitat Internacional de Catalunya

研究点 (4)

Loading locations...

相似试验