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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687619
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hülya Özbeşer, Eastern Mediterranean University

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE March 5, 2019
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Nine Hole Peg Test [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    It is a semi-structured questionnaire which will indicate the satisfaction level of parents from both approaches.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome, Trisomy 21
Intervention  ICMJE
  • Other: CO-OP
    Interventions (from top to down) related to the development of fine-motor skills
  • Other: Conductive Education
    Interventions (from down to top) related to the development of fine-motor skills
Study Arms  ICMJE
  • Experimental: CO-OP
    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.
    Intervention: Other: CO-OP
  • Experimental: Conductive Education
    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: Other: Conductive Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
10
Actual Study Completion Date  ICMJE August 1, 2020
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03687619
Other Study ID Numbers  ICMJE ETK00-218-0213
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hülya Özbeşer, Eastern Mediterranean University
Study Sponsor  ICMJE Eastern Mediterranean University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emine H. Tüzün, Prof. Dr. Instructor
Principal Investigator: Hülya Özbeşer, MSc. PT Instructor
Principal Investigator: Levent Eker, M. D. Instructor
PRS Account Eastern Mediterranean University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP