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

Down Syndrome, Trisomy 21 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687619
• Other study ID #: ETK00-218-0213
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 1, 2020
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Down Syndrome, Trisomy 21
• Syndrome

Intervention

Other:
• CO-OP
Interventions (from top to down) related to the development of fine-motor skills
• Conductive Education
Interventions (from down to top) related to the development of fine-motor skills

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	Parent Satisfaction Form	It is a semi-structured questionnaire which will indicate the satisfaction level of parents from both approaches.	12 weeks