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临床试验/NCT00400712
NCT00400712已完成不适用

Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?

Queen's University4 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2006年12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
103
试验地点
4
主要终点
Subjective Index of Physical Integration (Subscale of SIPSO)

研究概览

简要总结

Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.

详细描述

The extent to which impairment (physical capacity) and function influence community reintegration is unclear. One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level. Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months. It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration. This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration. Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals. Assessors will be blind to whether the subject is receiving a tune up. Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.

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
Single (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

  • first major unilateral hemispheric stroke,
  • english speaking,
  • adequate verbal communication,
  • discharged home or residential care

排除标准

  • serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)

结局指标

主要结局

Subjective Index of Physical Integration (Subscale of SIPSO)

时间窗: baseline and one year

see 'Subjective Index of Physical and Social Outcome (SIPSO) above

Subjective Index of Physical and Social Outcome (SIPSO)

时间窗: baseline and 1 year

The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.

Subjective Index of Social Integration (Subscale of SIPSO)

时间窗: baseline and one year

see Subjective Index of Physical and Social Outcome (SIPSO) above

次要结局

  • Mobility Function(baseline and 1 year)
  • Physical Capacity(baseline and 12 months)
  • Health-related Quality of Life - Physical(baseline and one year)
  • Health-related Quality of Life - Mental(baseline and one year)

研究者

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

Dr. Brenda Brouwer

Principle investigator

Queen's University

研究点 (4)

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