The Effect of the Cognitive Orientation to Daily Occupational Performance Approach for Children With Organic Acidemia
NCT ID: NCT04904705
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2020-06-22
2021-10-04
Brief Summary
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The hypotheses of the study are as follows:
* Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on daily life activities.
* Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on quality of life.
* Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on participation.
Detailed Description
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It was planned to include children between the ages of 7-12 who were diagnosed with organic acidemia in this study. In consequence of the statistical power analysis, the number of individuals to participate in the study was determined as 34 children diagnosed with organic acidemia, including 17 in the intervention group and 17 in the control group. The study will be conducted in a randomized controlled method. Children will be divided into intervention and control groups by using a computer-assisted online randomization application that provides an equal number and probability. Participants will be randomly numbered and randomly assigned to the intervention or control group without repeating the same number with the online randomization application available at randomizer.org. Both groups will be given a home program. Home programs will be prepared and sent to the person via e-mail. The Cognitive Orientation for Daily Activity Performance (CO-OP) Approach to the intervention group will be applied by video conferencing method in a total of 10 sessions, 2 sessions per week, through 5 weeks, and a total of 12 sessions with initial and final evaluations.
The children to be included in our study will be determined among the children with organic acidemia who are directed from Hacettepe University Metabolism and Nutrition Department. The contact information of the volunteers who agree to participate in the study will be given to the occupational therapist. The occupational therapist will provide information on how to download and use the video interview program called Zoom on his/her phone or computer. The session schedule will be determined after the program is set up. The program named Zoom was preferred because it is free, easy to install, and accessible compared to the other video conference programs.
The informed consent form will be sent to the individuals online by using Google Forms. After the participants approve the consent form, they will reach the evaluations to be prepared on Google Forms. One of the evaluation scales, the Canadian Occupational Performance Measure (COPM) will be made over the video interview. If they do not want to approve the consent form, they will be exempted from the study by checking the "I do not approve" option.
In this study, Canadian Occupational Performance Measure (COPM), Pediatric Evaluation of Disability Inventory (PEDI), The Child and Adolescent Scale of Participation (CASP), Quality of Life Questionnaire for Children (Kid-KINDL), Assistance to Participate Scale, and Sociodemographic Questionnaire will be implemented.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
It will be given a home program. Then The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach will be applied by video conferencing method in a total of 10 sessions, 2 sessions per week, through 5 weeks, and a total of 12 sessions with initial and final evaluations.
The Cognitive Orientation for Daily Activity Performance (CO-OP) approach is a person-oriented, performance-solving. and problem-solving approach that enables strategy acquisition and guided exploration for the acquisition and learning of new skills.
The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach is a cognitive-based approach. This is a person-oriented, performance-solving problem-solving approach that enables strategy acquisition and guided exploration for the acquisition and learning of new skills.
The main objectives of this approach are; define and transfer domain-specific strategies to other motor-based tasks to gain skills, learn problem-solving strategy (goal, plan, do, check) and adapt to other environments (such as home, school).
Home Program
Home Program are activities that a participant can apply at home to improve their skills.
Home Program
It will be given a home program only.
Home Program
Home Program are activities that a participant can apply at home to improve their skills.
Interventions
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The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach is a cognitive-based approach. This is a person-oriented, performance-solving problem-solving approach that enables strategy acquisition and guided exploration for the acquisition and learning of new skills.
The main objectives of this approach are; define and transfer domain-specific strategies to other motor-based tasks to gain skills, learn problem-solving strategy (goal, plan, do, check) and adapt to other environments (such as home, school).
Home Program
Home Program are activities that a participant can apply at home to improve their skills.
Eligibility Criteria
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Inclusion Criteria
* Being diagnosed with organic acidemia
* Being able to read and write
* Having sufficient language skills to be able to communicate and be understood during the intervention
Exclusion Criteria
* Having significant vision or hearing problems
* Refusing to participate in the study.
7 Years
12 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Esra Leman Dursun
Occupational Therapist
Principal Investigators
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Gonca Bumin, Ph.D.
Role: STUDY_DIRECTOR
Hacettepe University
Locations
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Hacettepe University
Ankara, Altindag, Turkey (Türkiye)
Countries
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Other Identifiers
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KA-20057
Identifier Type: -
Identifier Source: org_study_id