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

NCT ID: NCT06231901

Last Updated: 2024-04-05

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Occupational Problems Cognitive Orientation Goals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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coop plus traditional occupational therapy

This group received the traditional occupational therapy plus CO-OP approach.

Group Type EXPERIMENTAL

CO-OP

Intervention Type OTHER

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.

traditional occupational therapy

Intervention Type OTHER

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.

GDT plus traditional occupational therapy

This group received the traditional occupational therapy plus Goal directed training.

Group Type EXPERIMENTAL

GDT

Intervention Type OTHER

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

traditional occupational therapy

Intervention Type OTHER

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.

traditional occupational therapy

This group only received the traditional occupational therapy .

Group Type OTHER

traditional occupational therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach goal directed training

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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ZEYNEP KOLİT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zeynep kolit, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Rüya gül temel, MSc

Role: PRINCIPAL_INVESTIGATOR

HATAY MUSTAFA KEMAL ÜNİVERSİTESİ

Gamze ekici, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CG24

Identifier Type: -

Identifier Source: org_study_id

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