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Clinical Trials/NCT03687619
NCT03687619
Completed
Not Applicable

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

Eastern Mediterranean University1 site in 1 country12 target enrollmentMarch 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Down Syndrome, Trisomy 21
Sponsor
Eastern Mediterranean University
Enrollment
12
Locations
1
Primary Endpoint
performance quality rating scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2019
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hülya Özbeşer

PT. Ms

Eastern Mediterranean University

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

Outcomes

Primary Outcomes

performance quality rating scale

Time Frame: 12 weeks

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 Outcomes

  • Bruininks-Oseretsky Motor Proficiency Test - Brief Form(12 weeks)
  • Goal Attainment Scaling(12 weeks)
  • Parent Satisfaction Form(12 weeks)
  • Nine Hole Peg Test(12 weeks)
  • Dynamic Performance Analysis(12 weeks)
  • Canadian Occupational Performance Measure(12 weeks)
  • Child Health Questionnaire- Parent Form(12 weeks)

Study Sites (1)

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