Clinical trial NCT04308200: The Effect of the CO-OP Approach for Children With Cerebral Palsy
Official title: The Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Children With Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Cognitive Orientation
Keywords: Cerebral Palsy
Cognitive Orientation
occupations
functional status
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: It was re-applied 5 weeks after the baseline evaluations were made.
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: It was re-applied 5 weeks after the baseline evaluations were made.
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: It was applied to the caregivers of the CO-OP + NDT group within 1 days after 5 weeks of training.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Zeynep Kolit, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Gamze Ekici Çağlar, PhD
role: STUDY_DIRECTOR
References: