search
Back to results

Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome

Primary Purpose

Down Syndrome, Trisomy 21

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
CO-OP
Conductive Education
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome, Trisomy 21

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged between 7 and 18 years
  • Children who can understand cognitive skills given and can verbally communicate
  • Children who can specify at least 3 activities
  • Children who have adequate motivation

Exclusion Criteria:

  • Caregivers or parents who have inadequate cognitive levels for the study progression
  • Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months
  • Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program.
  • Children who have other neurological problems (except Down Syndrome)
  • Children who have undergone orthopedic surgery related to upper limbs
  • Children who have other health and behavioral problems which can affect the participation in the study

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CO-OP

Conductive Education

Arm Description

Cognitive Orientation to daily Occupational Performance (CO-OP) is a top-down approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks.

Conductive Education is a down-top approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks.

Outcomes

Primary Outcome Measures

performance quality rating scale
The PQRS rates performance quality on a 10-point scale, with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. An independent observer rates performances from video recorded trials of each skill at all assessment points.

Secondary Outcome Measures

Nine Hole Peg Test
The Nine-Hole Peg Test is a timed dexterity test that evaluates the ability to pick up nine 1¼-inch-long plastic pegs from a shallow dish, place them one at a time into a pegboard, and remove them one at a time back into the dish. The total time to complete the task for each hand will be recorded in seconds.
Bruininks-Oseretsky Motor Proficiency Test - Brief Form
It will be used to determine the motor skills of the children. Bilateral coordination, balance, strength and speed-agility will be measured to specify gross motor skills, while fine motor precision, fine motor integration, manual dexterity, and upper limb coordination will be measured for fine motor skills.
Canadian Occupational Performance Measure
The COPM is an outcome measure that, through a semi-structured interview, is designed to (a) identify and prioritize occupational performance issues or goals, and (b) measure clients' self perceived changes in occupational performance and satisfaction with their performance over time, of identified goals.
Dynamic Performance Analysis
DPA is a dynamic, iterative process, carried out as the client performs the occupation. The purpose of DPA is to identify where performance breaks down and test out solutions.This analysis will be used within the concept of CO-OP.
Child Health Questionnaire- Parent Form
The CHQ PF-50 is a 50 item, parent-completed questionnaire designed to measure the physical and psychosocial well-being of children with and without chronic conditions. Reliability and validity of Turkish version have been shown. The CHQ PF-50 measures components of physical and psychosocial functioning in 12 categories (subscales). The subscales used for our analyses included: physical functioning, role/social limitations (note: we call this subscale "School & Friends" since it measures the degree to which schoolwork or activities with friends are limited due to problems with physical health), bodily pain/ discomfort, mental health, and self-esteem.
Goal Attainment Scaling
The goal attainment scale is characterised by five levels of achievement. The expected outcome is the middle or 'zero' score. This expected outcome is determined first and then two better and two worse outcomes are documented. It enables individualised goals to be set and allows measurement of clinically important change which may not be detected by standardised assessments
Parent Satisfaction Form
It is a semi-structured questionnaire which will indicate the satisfaction level of parents from both approaches.

Full Information

First Posted
September 26, 2018
Last Updated
August 5, 2020
Sponsor
Eastern Mediterranean University
search

1. Study Identification

Unique Protocol Identification Number
NCT03687619
Brief Title
Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome
Official Title
The Effects of Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Fine Motor Skills, Activity and Participation Limitations in Children With Down Syndrome: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
December 22, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week in the cross-over randomized study. Following 12-week wash-out period, interventions will be changed for each group.
Detailed Description
Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments can be seen in children with DS. These impairments probably affect the development and learning of their various fundamental and complex actions. Those children experience decreased motor proficiency, reduced social participation and lower life quality. Fine motor skills are important for children's everyday functioning such as dressing, feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to cognitive, social and academic abilities in children. This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both intervention will be applied as groups including 3-4 children. Following 12-week wash-out period, interventions will be changed for each group. Two meetings before and during the study will be done in order to inform parents about the interventions and their effects. Another investigator who is blind about the groups will conduct the assessments before and after both first and second treatment durations so 4 assessments will be done in total. At the end of whole treatment schedule, a satisfaction form will be asked from the parents for feedback about both interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Trisomy 21

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO-OP
Arm Type
Experimental
Arm Description
Cognitive Orientation to daily Occupational Performance (CO-OP) is a top-down approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks.
Arm Title
Conductive Education
Arm Type
Experimental
Arm Description
Conductive Education is a down-top approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks.
Intervention Type
Other
Intervention Name(s)
CO-OP
Intervention Description
Interventions (from top to down) related to the development of fine-motor skills
Intervention Type
Other
Intervention Name(s)
Conductive Education
Intervention Description
Interventions (from down to top) related to the development of fine-motor skills
Primary Outcome Measure Information:
Title
performance quality rating scale
Description
The PQRS rates performance quality on a 10-point scale, with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. An independent observer rates performances from video recorded trials of each skill at all assessment points.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Nine Hole Peg Test
Description
The Nine-Hole Peg Test is a timed dexterity test that evaluates the ability to pick up nine 1¼-inch-long plastic pegs from a shallow dish, place them one at a time into a pegboard, and remove them one at a time back into the dish. The total time to complete the task for each hand will be recorded in seconds.
Time Frame
12 weeks
Title
Bruininks-Oseretsky Motor Proficiency Test - Brief Form
Description
It will be used to determine the motor skills of the children. Bilateral coordination, balance, strength and speed-agility will be measured to specify gross motor skills, while fine motor precision, fine motor integration, manual dexterity, and upper limb coordination will be measured for fine motor skills.
Time Frame
12 weeks
Title
Canadian Occupational Performance Measure
Description
The COPM is an outcome measure that, through a semi-structured interview, is designed to (a) identify and prioritize occupational performance issues or goals, and (b) measure clients' self perceived changes in occupational performance and satisfaction with their performance over time, of identified goals.
Time Frame
12 weeks
Title
Dynamic Performance Analysis
Description
DPA is a dynamic, iterative process, carried out as the client performs the occupation. The purpose of DPA is to identify where performance breaks down and test out solutions.This analysis will be used within the concept of CO-OP.
Time Frame
12 weeks
Title
Child Health Questionnaire- Parent Form
Description
The CHQ PF-50 is a 50 item, parent-completed questionnaire designed to measure the physical and psychosocial well-being of children with and without chronic conditions. Reliability and validity of Turkish version have been shown. The CHQ PF-50 measures components of physical and psychosocial functioning in 12 categories (subscales). The subscales used for our analyses included: physical functioning, role/social limitations (note: we call this subscale "School & Friends" since it measures the degree to which schoolwork or activities with friends are limited due to problems with physical health), bodily pain/ discomfort, mental health, and self-esteem.
Time Frame
12 weeks
Title
Goal Attainment Scaling
Description
The goal attainment scale is characterised by five levels of achievement. The expected outcome is the middle or 'zero' score. This expected outcome is determined first and then two better and two worse outcomes are documented. It enables individualised goals to be set and allows measurement of clinically important change which may not be detected by standardised assessments
Time Frame
12 weeks
Title
Parent Satisfaction Form
Description
It is a semi-structured questionnaire which will indicate the satisfaction level of parents from both approaches.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged between 7 and 18 years Children who can understand cognitive skills given and can verbally communicate Children who can specify at least 3 activities Children who have adequate motivation Exclusion Criteria: Caregivers or parents who have inadequate cognitive levels for the study progression Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program. Children who have other neurological problems (except Down Syndrome) Children who have undergone orthopedic surgery related to upper limbs Children who have other health and behavioral problems which can affect the participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine H. Tüzün, Prof. Dr.
Organizational Affiliation
Instructor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hülya Özbeşer, MSc. PT
Organizational Affiliation
Instructor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Levent Eker, M. D.
Organizational Affiliation
Instructor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus

12. IPD Sharing Statement

Learn more about this trial

Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome

We'll reach out to this number within 24 hrs