The Effect of the CO-OP Approach for Children With Cerebral Palsy

ZEYNEP KOLİT

Status: Completed

Conditions: Cognitive Orientation; Cerebral Palsy

Treatments: Other: NDT; Other: CO-OP approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04308200

GO 18/624

Details and patient eligibility

About

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.

Full description

Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22 (IBM SPSS Statistics; IBM Corporation, Armonk, NY). One sample Kolmogorov-Smirnov Test was used evaluate the distribution of variables prior to test selection. Group characteristics and outcome measures are described using mean and standard deviations for continuous variables and frequencies and proportions for categorical variables. Descriptive statistics were presented as median for the non-normally distributed quantitative and ordinal data and number (percentage) for the categorical variables. Differences in continuous variables (age, education, BMI, duration of diagnosis,) among groups were analyzed with the Mann Whitney U. Statistical differences in COPM and PEDI scores between baseline and post-treatment was analyzed with "Wilcoxon's signed-rank test" within groups. The z-score obtained from the Wilcoxon signed-rank test was reported to present a standardized measure of the difference between the mean ranks of the negative and positive groups. Comparison of changes between groups were analyzed with "Mann-Whitney U" test for COPM and PEDI scores. Statistical significance level was assumed at p<0.05.

Clinical significance was calculated by using the Cohen d effect size index in independent groups. Clinical significance was determined according to Cohen's recommended limit values (0,2 small; 0,5 moderate and 0,8 large effect).

Enrollment: 36 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

CO-OP+NDT group

Other group

Description:

The CO-OP+NDT group received twelve sessions of CO-OP approach, with the baseline and end of treatment assessments, each lasting approximately one hour. Parents and / or caregivers were advised to observe sessions as often as possible to encourage adaptation and transfer to life. Furthermore, CO-OP+NDT group received NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist.

Treatment:

Other: NDT

Other: CO-OP approach

NDT group

Other group

Description:

NDT group received just NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist. The NDT protocol is improving muscular tone and movement patterns. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity and postural reactions.

Treatment:

Other: NDT