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
Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living
Sponsors
Source
University of Extremadura
Oversight Info
Has Dmc
No
Brief Summary
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.
Detailed Description
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).
Overall Status
Completed
Start Date
2012-11-01
Completion Date
2013-04-01
Primary Completion Date
2013-02-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Dependency level |
after 5 weeks of treatment and after 6 weeks of follow up |
Secondary Outcome
Measure |
Time Frame |
|
Cognitive level. |
After 5 weeks of treatment and after 6 weeks of follow up |
Enrollment
58
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Stimulation of Activities Daily Living
Other Name
Occupational therapy
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Conventional ADLoccupational therapy
Eligibility
Criteria
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.
Gender
All
Minimum Age
60 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Maria Jimenez, Professor |
Principal Investigator |
University of Extremadura |
Location
Facility |
|
'CARE' elderly residential homes Cáceres 10004 Spain |
Location Countries
Country
Spain
Verification Date
2014-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Extremadura
Investigator Full Name
MARIA JIMENEZ PALOMARES
Investigator Title
Profesor of Occupational Therapy
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Stimulation of Activities Daily Living
Arm Group Type
Experimental
Description
The experimental group received the Stimulation of Activities of Daily Living (SADL) programme which is a new treatment approach created by the authors of this study for the training of activities of daily living (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 sequence of the sessions was always the same, varying the activities, subject, cognitive functions and BADL to work on. Each session started with an activity of temporal and space orientation, continued with the performance of the specific activity of the session and finished with a reminiscence activity.
The treatment was applied twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.
Arm Group Label
Conventional ADLoccupational therapy
Arm Group Type
Active Comparator
Description
The control group treatment was based on a 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.
Firstreceived Results Date
N/A
Acronym
OTSALD
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Study First Submitted
July 22, 2014
Study First Submitted Qc
July 22, 2014
Study First Posted
July 24, 2014
Last Update Submitted
July 24, 2014
Last Update Submitted Qc
July 24, 2014
Last Update Posted
July 25, 2014
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.