<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02199353</url>
  </required_header>
  <id_info>
    <org_study_id>46/2012</org_study_id>
    <nct_id>NCT02199353</nct_id>
  </id_info>
  <brief_title>Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living</brief_title>
  <acronym>OTSALD</acronym>
  <official_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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Extremadura</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL)&#xD;
      Occupational Therapy programme on the independence of ADL by persons with dementia who are&#xD;
      institutionalized. This programme is based on the recovery of the cognitive functions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a longitudinal and prospective clinical trial approved by the bioethics&#xD;
      Commission of the University of Extremadura. 58 senior citizens institutionalized with&#xD;
      dementia in residential homes in Extremadura (Spain) received a treatment focusing on&#xD;
      activities of daily living with the SADL programme and with conventional occupational therapy&#xD;
      during 5 weeks. The studied variables were the cognitive level and the independence level&#xD;
      performing ADL. The variables were measured by an occupational therapist independent to the&#xD;
      study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment&#xD;
      was completed. The standardized tests used were Barthel Index, Lobo's Cognoscitive mini test,&#xD;
      Lawton and Brody Scale and Global Deterioration Scale (GDS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dependency level</measure>
    <time_frame>after 5 weeks of treatment and after 6 weeks of follow up</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive level.</measure>
    <time_frame>After 5 weeks of treatment and after 6 weeks of follow up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Stimulation of Activities Daily Living</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
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.&#xD;
The treatment was applied twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional ADLoccupational therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stimulation of Activities Daily Living</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.&#xD;
The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.</description>
    <arm_group_label>Stimulation of Activities Daily Living</arm_group_label>
    <other_name>Occupational therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional ADLOccupational Therapy</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.&#xD;
The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.</description>
    <arm_group_label>Conventional ADLoccupational therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Institutionalization in residential homes at least 6 months before the commencement of&#xD;
             the study.&#xD;
&#xD;
          -  Diagnosis of dementia for at least one year according to the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DMS IV) criteria.&#xD;
&#xD;
          -  Over 60 years old.&#xD;
&#xD;
          -  Barthel Index scores greater than or equal to 40%.&#xD;
&#xD;
          -  Lobo´s Cognitive Mini Test scores greater than or equal to 15 points.&#xD;
&#xD;
          -  To be included in the BADL intervention programme of Occupational therapy in the&#xD;
             previous 6 months and to have the informed consent signed by the legal tutor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To present psychological or behavior symptoms diagnosed by a doctor.&#xD;
&#xD;
          -  Barthel Index scores less than 40%&#xD;
&#xD;
          -  Not being included in the BADL intervention programme of Occupational therapy in the&#xD;
             previous 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Jimenez, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Extremadura</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>'CARE' elderly residential homes</name>
      <address>
        <city>Cáceres</city>
        <zip>10004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Extremadura</investigator_affiliation>
    <investigator_full_name>MARIA JIMENEZ PALOMARES</investigator_full_name>
    <investigator_title>Profesor of Occupational Therapy</investigator_title>
  </responsible_party>
  <keyword>Activities of daily living, Occupational Therapy, Dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02199353
org study id: 46/2012
nct id: NCT02199353
lead sponsor: 
has dmc: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Dependency level
time frame: after 5 weeks of treatment and after 6 weeks of follow up
description: 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
measure: Cognitive level.
time frame: After 5 weeks of treatment and after 6 weeks of follow up
description: 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.
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.
intervention type: Other
intervention name: Stimulation of Activities Daily Living
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: Conventional ADLOccupational Therapy
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
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Jimenez, Professor
role: Principal Investigator
affiliation: University of Extremadura
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Extremadura
investigator full name: MARIA JIMENEZ PALOMARES
investigator title: Profesor of Occupational Therapy
mesh term: Dementia