The Effect of the Cognitive Orientation to Daily Occupational Performance Approach for Children With Organic Acidemia

NCT04904705 | Completed

• 1 other identifier: KA-20057
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to research the effect of Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) on daily life activities, quality of life and participation in children with organic acidemia. 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.

Conditions

Organic Acidemia; Cognitive Orientation

Keywords

Organic Acidemia; Cognitive Orientation; Activities of Daily Living; Participation; Quality of Life; Telerehabilitation

Outcome Measures

Primary Outcomes (6)

• Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure (COPM) is designed to be used for client-centred clinical practice. The COPM is an outcome measure designed for use by occupational therapists to assess client outcomes in the areas of self-care, productivity and leisure. Using a semi-structured interview, the COPM is a five step process which measures individual, client-identified problem areas in daily function. Two scores, for performance and satisfaction with performance are obtained.

  In the first week and the sixth week

• Quality of Life Questionnaire for Children (Kid-KINDL)

  The Kid-KINDL questionnaire contains 6 dimensions (viz, physical well-being, emotional well-being, self-esteem, friends, family, and school), each of them including 4 items. Each item in the test is 5-point Likert-scaled (positively worded items: never scores 1 and always scores 5; negatively worded items: never scores 5 and always scores 1). 7 From the item scores, the total Kid-KINDL score and each dimension score can be calculated and transformed into a 0 to 100 result.

  In the first week and the sixth week

• The Child and Adolescent Scale of Participation (CASP)

  The CASP specifically measures children's extent of participation and restrictions in home, school and community life situations and activities compared to same-age peers as reported by family caregivers. It consists of 20 items divided into four sub-sections: (1) Home Participation, (2) School Participation, (3) Community Participation and (4) Home and Community Living Activities. Each item addresses a broad participation domain with examples provided for each domain (see Appendix for item descriptions). The 20 items are rated on a 4-point scale (4 = Age expected, 3 = Somewhat restricted, 2 = Very restricted, 1 = Unable) or as 'Not applicable'.

  In the first week and the sixth week

• Pediatric Evaluation of Disability Inventory (PEDI)

  The Pediatric Evaluation of Disability Inventory (PEDI) is a comprehensive functional assessment designed for use by physical and occupational therapists, as well as other rehabilitation and educational professionals. The PEDI measures both functional performance and capability in three domains: (1) self-care, (2) mobility, and (3) social function. The PEDI consists of 197 functional skill items, and 20 items that assess caregiver assistance and modifications.

  In the first week and the sixth week

• Assistance to Participate Scale (APS)

  Assistance to Participate Scale (APS) measures the level of assistance that a school-aged child with a disability needs to participate in game, leisure, and recreational activities at home and in the community, from the perspective of the primary caregiver. It takes 5-10 min to answer the APS by the caregivers. Participants were asked to rate the level of assistance that they typically provide to their child on a 5-point ordinal scale (1 = Unable to participate; 2 = Participates with my assistance at all stages of the activity; 3 = Participates after I have set him/her up and help at times during the activity; 4 = Participates with my supervision only; 5 = Participates independently). The minimum and maximum scores range between 8 and 40. Lower scores indicate requirement of higher levels of assistance.

  In the first week and the sixth week

• Sociodemographic Questionnaire

  Data on gender, age, height, weight, dominant hand, school class, medicine names used before will be collected.

  In the first week

Study Arms (2)

Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach

ACTIVE COMPARATOR

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.

Other: The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach; Other: Home Program

Home Program

ACTIVE COMPARATOR

It will be given a home program only.

Other: Home Program

Interventions

The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach OTHER

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).

Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach

Home Program OTHER

Home Program are activities that a participant can apply at home to improve their skills.

Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach; Home Program

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 7-12
• 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

You may not qualify if:

• Being on other treatment
• Having significant vision or hearing problems
• Refusing to participate in the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Orientation, Spatial

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Gonca Bumin, Ph.D.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: 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. 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 that will be prepared and sent to the person via e-mail. The Cognitive Orientation for Daily Occupational 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.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: June 22, 2020
• Primary Completion: December 22, 2020
• Study Completion: October 4, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)