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

NCT ID: NCT03687619

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2020-08-01

Brief Summary

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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

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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.

Conditions

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Down Syndrome, Trisomy 21

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CO-OP

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Conductive Education

Intervention Type OTHER

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

Interventions

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CO-OP

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

Intervention Type OTHER

Conductive Education

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Hülya Özbeşer

PT. Ms

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine H. Tüzün, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Instructor

Hülya Özbeşer, MSc. PT

Role: PRINCIPAL_INVESTIGATOR

Instructor

Levent Eker, M. D.

Role: PRINCIPAL_INVESTIGATOR

Instructor

Locations

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Eastern Mediterranean University

Famagusta, , Cyprus

Site Status

Countries

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Cyprus

Other Identifiers

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ETK00-218-0213

Identifier Type: -

Identifier Source: org_study_id

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