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

NCT03687619 | Completed

• 1 other identifier: ETK00-218-0213
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome, Trisomy 21

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Nine Hole Peg Test

  12 weeks

• Bruininks-Oseretsky Motor Proficiency Test - Brief Form

  12 weeks

• Canadian Occupational Performance Measure

  12 weeks

• Dynamic Performance Analysis

  12 weeks

• Child Health Questionnaire- Parent Form

  12 weeks

Study Arms (2)

CO-OP

EXPERIMENTAL

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.

Other: CO-OP

Conductive Education

EXPERIMENTAL

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.

Other: Conductive Education

Interventions

CO-OP OTHER

Interventions (from top to down) related to the development of fine-motor skills

CO-OP

Conductive Education OTHER

Interventions (from down to top) related to the development of fine-motor skills

Conductive Education

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Emine H. Tüzün, Prof. Dr.

  Instructor

  PRINCIPAL INVESTIGATOR

• Hülya Özbeşer, MSc. PT

  Instructor

  PRINCIPAL INVESTIGATOR

• Levent Eker, M. D.

  Instructor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT. Ms

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: March 5, 2019
• Primary Completion: December 22, 2019
• Study Completion: August 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

CY (1)