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NCT Number: NCT02199353

Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

'CARE' elderly residential homes

Cáceres, 10004, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Stimulation of Activities Daily Living

Other

Experimental group: SADL programme which is a new treatment approach created by the authors of this study for the training of ADL through cognitive intervention. The programme is based on the reestablishment of the cognitive functions implied in the performance of basic activities of daily living.

The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.

Other names: Occupational therapy

Conventional ADLOccupational Therapy

Other

Control group treatment: conventional occupational therapy intervention for the management of ADL deficits. The compensation approach was used and environment modifications and simplification of activities were applied as the intervention method.

The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.

Primary outcomes

  1. Dependency level

    Time frame: 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

Secondary outcomes

  1. Cognitive level.

    Time frame: After 5 weeks of treatment and after 6 weeks of follow up

    To assess the cognitive level and guarantee the homogeneity of the sample, the adapted and validated Spanish version of the Mini Mental Status Examination (MMSE) test by Lobo et al was used. The Global Deterioration Scale (GDS) designed by Reisberg et al was also used to determine the deterioration level.

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

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

Acronym: OTSALD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2014
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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