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临床试验/NCT01674452
NCT01674452已完成不适用

Home-based Exercises for Patients With Stroke

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年1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
90
试验地点
2
主要终点
Functional Independence Measure

研究概览

简要总结

The aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke.

The hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

详细描述

  1. Program Development: 27 exercises were selected, based on the most frequent motor alterations present in hemiparesis. Three modes were created for each exercise: assisted active, active and resisted active executions. Besides explanatory text, there were illustrative photos for all exercises and their modes.
  2. Program Execution: All groups were submitted to a motor evaluation utilizing the Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional independence measure (FIM). After assessment, for the patients of the home-based exercise group (HBG) a group of home exercises was selected for each patient; these exercises were explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when any necessary correction was made. The next steps stipulated by the manual were taken, providing the patients with more complex exercises according to their progress. The patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions two times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).The control group (CG) was assessed but reluctant or unable to regularly attend a supervised exercise program. The groups were reassessed after six months.
  3. Program assessment: The Fugl-Meyer Assessment score and the Functional independence measure score, measured at baseline and after six months, were compared between the groups.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of stroke, confirmed by clinical and radiological evidence
  • Ability to understand and follow commands
  • willing and able to regularly attend a supervised exercise program

排除标准

  • severe cognitive impairment
  • Commodity that preclude them from undergoing training and assessment
  • Neurological disease other than stroke

结局指标

主要结局

Functional Independence Measure

时间窗: 6 months

Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.

次要结局

  • motor performance, Fugl-Meyer scale(6 months)

研究者

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

Maria Elisa Pimentel Piemonte

PT; PhD

University of Sao Paulo General Hospital

研究点 (2)

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