Comparison of CO-OP and GDT on Occupational Performance and Functional Status in the CP

April 4, 2024 updated by: ZEYNEP KOLİT, Hacettepe University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sıhhiye
      • Ankara, Sıhhiye, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: coop plus traditional occupational therapy
This group received the traditional occupational therapy plus CO-OP approach.
Other: CO-OP
With a task-specific and goal-focused CO-OP approach; it is aimed to increase one's skills, to teach to use self-generated cognitive strategies, and to encourage generalization and transfer to new situations and activities.
Other Names:
  • Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
Other: traditional occupational therapy
The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.
Experimental: GDT plus traditional occupational therapy
This group received the traditional occupational therapy plus Goal directed training.
Other: traditional occupational therapy
The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.
Other: GDT
Goal-directed training included the active implementation of task-specific activities related to the child's functional goals. Focusing on motor learning, GDT is an activity-based approach to therapy that uses meaningful, self-selected goals to provide opportunities for problem solving and indirectly guide the movements necessary to successfully meet task demands
Other Names:
  • goal directed training
Other: traditional occupational therapy
This group only received the traditional occupational therapy .
Other: traditional occupational therapy
The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
"up to 12 weeks"
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.
"up to 12 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: zeynep kolit, MSc, Hacettepe University
  • Principal Investigator: Rüya gül temel, MSc, Hatay Mustafa Kemal Üniversitesi
  • Study Director: Gamze ekici, PhD, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CG24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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