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临床试验/NCT02199353
NCT02199353已完成不适用

Effectiveness of A Therapy Programme Based On The Reestablishment of Cognitive Functions on The Independence of Patients With Dementia Performing Activities of Daily Living - A Pilot Study

University of Extremadura2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Dependency level

研究概览

简要总结

To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL) Occupational Therapy programme on the independence of ADL by persons with dementia who are institutionalized. This programme is based on the recovery of the cognitive functions.

详细描述

This study is a longitudinal and prospective clinical trial approved by the bioethics Commission of the University of Extremadura. 58 senior citizens institutionalized with dementia in residential homes in Extremadura (Spain) received a treatment focusing on activities of daily living with the SADL programme and with conventional occupational therapy during 5 weeks. The studied variables were the cognitive level and the independence level performing ADL. The variables were measured by an occupational therapist independent to the study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment was completed. The standardized tests used were Barthel Index, Lobo's Cognoscitive mini test, Lawton and Brody Scale and Global Deterioration Scale (GDS).

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Institutionalization in residential homes at least 6 months before the commencement of the study.
  • Diagnosis of dementia for at least one year according to the Diagnostic and Statistical Manual of Mental Disorders (DMS IV) criteria.
  • Over 60 years old.
  • Barthel Index scores greater than or equal to 40%.
  • Lobo´s Cognitive Mini Test scores greater than or equal to 15 points.
  • To be included in the BADL intervention programme of Occupational therapy in the previous 6 months and to have the informed consent signed by the legal tutor.

排除标准

  • To present psychological or behavior symptoms diagnosed by a doctor.
  • Barthel Index scores less than 40%
  • Not being included in the BADL intervention programme of Occupational therapy in the previous 6 months.

结局指标

主要结局

Dependency level

时间窗: after 5 weeks of treatment and after 6 weeks of follow up

In order to assess the basic activities of daily living (BADL), Barthel Index published in 1.965 by Mahoney y Barthel was applied. This scale provides information at a global level with the general scores (dependence level) and at a specific level with each item's score. A score of less than 20 means total dependence, 20-35 scores mean severe dependence, 40-55 scores mean moderate dependence, equal or over 60 means mild dependency and 100 means independence. This allows the assessment of any changes in each basic activity area evaluated with this scale

次要结局

  • Cognitive level.(After 5 weeks of treatment and after 6 weeks of follow up)

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

MARIA JIMENEZ PALOMARES

Profesor of Occupational Therapy

University of Extremadura

研究点 (2)

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