Clinical trial NCT03687619: 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
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome, Trisomy 21
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: performance quality rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Nine Hole Peg Test
timeFrame: 12 weeks
measure: Bruininks-Oseretsky Motor Proficiency Test - Brief Form
timeFrame: 12 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 12 weeks
measure: Dynamic Performance Analysis
timeFrame: 12 weeks
measure: Child Health Questionnaire- Parent Form
timeFrame: 12 weeks
measure: Goal Attainment Scaling
timeFrame: 12 weeks
measure: Parent Satisfaction Form
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Instructor
name: Emine H. Tüzün, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instructor
name: Hülya Özbeşer, MSc. PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Instructor
name: Levent Eker, M. D.
role: PRINCIPAL_INVESTIGATOR
References: