The Effect of the CO-OP Approach for Children With Cerebral Palsy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Cerebral Palsy
- Cognitive Orientation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study was a single blinded and randomized controlled trial. All children included in the study were evaluated by a single evaluator who was blind to therapy at baseline and at the end of treatment. The study was completed with a total of 30 individuals, 15 in the CO-OP+ neurodevelopmental therapy (NDT) and 15 in the NDT group. Both groups received 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. All children who met the inclusion criteria using GMFCS and MACS were evaluated with sociodemographic data, activity daily log, COPM and PEDI. The CO-OP group received twelve sessions of intervention, with the baseline and end of treatment assessments, each lasting approximately one hour.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 12 years
- Gender
- Both males and females
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 outcom...
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).
Tracking Information
- NCT #
- NCT04308200
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zeynep Kolit, MSc Hacettepe University Study Director: Gamze Ekici Ça?lar, PhD Hacettepe University
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