Cerebral Palsy Clinical Trial
Official title:
The Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Children With Cerebral Palsy: a Randomized Controlled Trial
Verified date | August 2021 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the literature, despite the reported positive findings of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, studies in this area have been limited and it is stated that studies involving more sample groups are needed (24-27). In addition, no studies investigating the effect of the CO-OP approach on functional status were found. The purpose of this study was to investigate the effects of CO-OP approach in terms of occupational performance and satisfaction also functional status in children with cerebral palsy (CP) and to determine parents' satisfaction level from CO-OP. The hypotheses of the study are: The CO-OP approach has no effect on occupational performance in children with CP. CO-OP approach has no effect on occupational satisfaction in children with CP. The CO-OP approach has no effect on the functional status of children with CP.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2, 2021 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: - being between 5-12 years of age - being diagnosed with CP - being at level I, II, or III according to the Gross Motor Function Classification Scale (GMFCS) - being at level I, or II according to the Manual Ability Classification System (MACS) - having experienced motor performance problems in daily activities, as reported by parents and/or children during interview; have sufficient language ability to communicate with and be understood during treatment. Exclusion Criteria: - receiving another treatment other than NDT - being diagnosed with mental retardation - having serious visual or hearing problems. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Sihhiye |
Lead Sponsor | Collaborator |
---|---|
ZEYNEP KOLIT |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Canadian Occupational Performance Measure (COPM) | The COPM was used in this study to establish goals for each child prior to intervention. It is a semi-structured interview designed to help clients identify occupational performance issues and priorities in the areas of self-care, productivity (school), and leisure, in which they have difficulty performing. In this study, children and their parents selected the "training goals" collaboratively by rating on a 10-point scale displaying their goals in terms of satisfaction and performance. The children and their parents scored the COPM independently before and after intervention based on goals set by the child and supported by the parents. Changes in performance and satisfaction scores before and after intervention were determined separately. A change score of two points or more on the COPM is considered clinically significant | It was re-applied 5 weeks after the baseline evaluations were made. | |
Primary | Pediatric Evaluation of Disability Inventory (PEDI) | PEDI is a clinical measurement tool developed by Haley et al to evaluate the functional status of children. In particular, it is arranged to determine the functions of young children . It can also be used for older children whose functional performance falls below that expected for 7.5- year-old normally developing children. PEDI consists of three main sections, functional skills, caregiver assistance and modifications. Each of these sections evaluates the areas of self-care, mobility and social function. Each of the PEDI subsections can be used separately. | It was re-applied 5 weeks after the baseline evaluations were made. | |
Secondary | Visual Analog Scale (VAS) | It is a reliable, easily applicable assessment tool that is accepted in the world literature. VAS is used to convert some non-quantifiable values into numeric data. It is the scale in which a person marks his / her current emotion level with a vertical line on a 10 cm scale. Every emotion is evaluated between the fact that the feeling is never experienced and that it is being experienced completely. Post-intervention satisfaction levels of the parents in the CO-OP group were determined using VAS. | It was applied to the caregivers of the CO-OP + NDT group within 1 days after 5 weeks of training. |
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