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a Water Training Program to Improve Balance in Chronic Stroke Patients

2008年12月15日 更新者:Soroka University Medical Center

a Water Training Program to Improve Balance in Chronic Stroke Patients: Cross- Sectional Pre-Post Study Design

The proposed project is a case control study design. Subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.

The whole project will be conducted over a period of 3 months. A total of 36 subjects will be assigned to water based exercise program. The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.

Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1) Medical background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument. 4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. For example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). These "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.

研究概览

研究类型

观察性的

注册 (预期的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 80年 (年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.

描述

Inclusion Criteria:

  1. Subjects suffer from chronic hemiplegia (a year or more)
  2. able to stand independently 90 seconds;
  3. able to walk 10 meters (with cane if necessary);
  4. able to understand verbal instructions.

Exclusion Criteria:

  1. Serious visual impairment;
  2. Inability to ambulate independently (cane acceptable, walker not).
  3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
  4. Persons with impaired communication capabilities.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
ChSt, water training, Observation
Subjects suffer from chronic hemiplegia (a year or more post stroke) that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.
The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.

研究衡量的是什么?

次要结果测量

结果测量
大体时间
Berg Balance Scale
大体时间:fall will be monitored a year after the completion of the study.
fall will be monitored a year after the completion of the study.
Late life Function and Disability Instrument
大体时间:fall will be monitored a year after the completion of the study
fall will be monitored a year after the completion of the study
Get up and go test - stand up and walk 3 meters turn around and walk back to the chair
大体时间:fall will be monitored a year after the completion of the study
fall will be monitored a year after the completion of the study
Step execution test under single and dual task
大体时间:fall will be monitored a year after the completion of the study
fall will be monitored a year after the completion of the study
Stability tests
大体时间:fall will be monitored a year after the completion of the study
fall will be monitored a year after the completion of the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dagan Shvartz, M.D.、Ben-gurion University of the Negev, Beer-Sheva, Israel

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年11月1日

初级完成 (实际的)

2008年5月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2007年11月25日

首先提交符合 QC 标准的

2007年11月26日

首次发布 (估计)

2007年11月27日

研究记录更新

最后更新发布 (估计)

2008年12月16日

上次提交的符合 QC 标准的更新

2008年12月15日

最后验证

2007年11月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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