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Clinical Trials/NCT06231901
NCT06231901
Completed
Not Applicable

Comparison of Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach and Goal-Directed Training on Occupational Performance and Functional Status in Children With Cerebral Palsy: A Three-Armed Randomized Controlled Trial

Hacettepe University1 site in 1 country60 target enrollmentJanuary 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Hacettepe University
Enrollment
60
Locations
1
Primary Endpoint
Pediatric Evaluation of Disability Inventory (PEDI):
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.

Detailed Description

Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.

Registry
clinicaltrials.gov
Start Date
January 17, 2024
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ZEYNEP KOLİT

Principal Investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • being between 5-10 years of age
  • being diagnosed with CP
  • having adequate language abilities to make contact with a therapist and be informed during intervention.

Exclusion Criteria

  • they were receiving any other treatment
  • they had been diagnosed with mental retardation
  • they had serious vision or hearing problems.

Outcomes

Primary Outcomes

Pediatric Evaluation of Disability Inventory (PEDI):

Time Frame: "up to 12 weeks"

PEDI is a measurement tool used to evaluate the functional status of children.

Canadian Occupational Performance Measure (COPM)

Time Frame: "up to 12 weeks"

COPM is used to help individuals describe occupational performance problems and precedence in the areas of self-care, productivity, and leisure, in which they have difficulty performing.

Study Sites (1)

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