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临床试验/NCT01460277
NCT01460277已完成不适用

Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

University of Ioannina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change of postural and sitting balance at six weeks

研究概览

简要总结

The purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional status measured with the Functional Independence Measure. Postural sway was evaluated with a pressure platform by using the variables of center of pressure (COP) displacements in the mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and evaluated using statistical programme SPSS.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hemiplegia or hemiparesis after stroke or traumatic brain injury
  • at least 6 months post-stroke from a single cerebrovascular accident
  • independent in walking (with or without assistive device)
  • clinical stable

排除标准

  • unstable cardiac conditions
  • urinary or faecal incontinence
  • open wounds
  • significant musculoskeletal problems in lower extremities from conditions other than stroke
  • Alzheimer
  • Parkinson's disease
  • polyneuropathy
  • vestibular disorders
  • current participation in an exercise program

结局指标

主要结局

Change of postural and sitting balance at six weeks

时间窗: At the time of admittance to the rehabilitation department (at baseline) and after six weeks

Postural balance and weight-bearing ability measured by vertical ground reaction force during standing, sitting and four standing tasks (rising from a chair and weight-shifting forward, backward and laterally)

次要结局

  • Change of function at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of balance at six weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of trunk control at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of leg's motion at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of posture at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of spasticity at six weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of leg's strength at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)

研究者

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

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

University of Ioannina

研究点 (1)

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