Cerebral PalsyNCT04308200
The Effect of the CO-OP Approach for Children With Cerebral Palsy
A study testing CO-OP approach and NDT in people with Cerebral Palsy and Cognitive Orientation, run by ZEYNEP KOLİT at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Cognitive Orientation
- What is being tested?
- CO-OP approach and NDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- receiving another treatment other than NDT
- being diagnosed with mental retardation
- having serious visual or hearing problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Children With Cerebral Palsy: a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Cerebral Palsy, Cognitive Orientation
- Being tested
- CO-OP approach, NDT
- Keywords
- Cerebral Palsy, Cognitive Orientation, occupations, functional status
- Medical subject headings
- Cerebral Palsy, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OP approachOther
There are 3 stages in the CO-OP approach. Stage I, the Preparation Stage, is primarily concerned with establishing the "goal". Before the first interview, the child was contacted, the family and the child were informed, and it was checked whether they met the prerequisites. At this stage, 3 targets were selected and the basic performance level was determined. Stage II, the Acquisition Stage, is essentially the "plan" and "do" stage, in which the work of using strategies to acquire skills is done. This stage originally comprised 10 sessions. At this stage, the first session enabling principles were implemented and the global strategy "goal-plan-do-check" was introduced. The family attended this process with observation. Parents / caregivers were encouraged to make observations to generalize strategies. Stage III, the Verificatíon stage usually consists of only one session in which "control" is performed; the progress made was revised as learned strategies.
NDTOther
All participations 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. Although the treatment activities varied for each CP participant, the overall goals (improved smoothness and efficiency of movement), which included improved trunk, hip, knee and ankle control, were the same for all CP participants. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity, weight-shifting and postural reactions.
| Study group | Role | What they receive |
|---|---|---|
| CO-OP+NDT group | Other | 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. Receives: Other: CO-OP approach; Other: NDT |
| NDT group | Other | 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. Receives: Other: NDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: It was re-applied 5 weeks after the baseline evaluations were made.
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.
Measured: It was re-applied 5 weeks after the baseline evaluations were made.
Secondary outcomes (1)
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.
Measured: It was applied to the caregivers of the CO-OP + NDT group within 1 days after 5 weeks of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Oct 2019
- Primary completion30 Nov 2019
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZEYNEP KOLİT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZEYNEP KOLİT, Hacettepe University
- Investigators
- Zeynep Kolit, MSc, Principal investigator, Hacettepe UniversityGamze Ekici Çağlar, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308200
- Sponsor's protocol ID
- GO 18/624
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Children With Cerebral Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04308200
- Acronym / sponsor ID
- GO 18/624
- Conditions
- Cerebral Palsy, Cognitive Orientation
- Keywords
- Cerebral Palsy, Cognitive Orientation, occupations, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ZEYNEP KOLİTUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CO-OP+NDT group | Other | Other: CO-OP approach, Other: NDTThe 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. |
| NDT group | Other | Other: NDTNDT 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- receiving another treatment other than NDT
- being diagnosed with mental retardation
- having serious visual or hearing problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-OP approachThere are 3 stages in the CO-OP approach. Stage I, the Preparation Stage, is primarily concerned with establishing the "goal". Before the first interview, the child was contacted, the family and the child were informed, and it was checked whether they met the prerequisites. At this stage, 3 targets were selected and the basic performance level was determined. Stage II, the Acquisition Stage, is essentially the "plan" and "do" stage, in which the work of using strategies to acquire skills is done. This stage originally comprised 10 sessions. At this stage, the first session enabling principles were implemented and the global strategy "goal-plan-do-check" was introduced. The family attended this process with observation. Parents / caregivers were encouraged to make observations to generalize strategies. Stage III, the Verificatíon stage usually consists of only one session in which "control" is performed; the progress made was revised as learned strategies. | Other | CO-OP+NDT group |
| NDTAll participations 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. Although the treatment activities varied for each CP participant, the overall goals (improved smoothness and efficiency of movement), which included improved trunk, hip, knee and ankle control, were the same for all CP participants. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity, weight-shifting and postural reactions. | Other | CO-OP+NDT group, NDT group |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: It was re-applied 5 weeks after the baseline evaluations were made.
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
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: It was re-applied 5 weeks after the baseline evaluations were made.
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.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: It was applied to the caregivers of the CO-OP + NDT group within 1 days after 5 weeks of training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Kolit, MSc principal investigator
Hacettepe University
Gamze Ekici Çağlar, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP approach and NDT in people with Cerebral Palsy and Cognitive Orientation, run by ZEYNEP KOLİT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: It was re-applied 5 weeks after the baseline evaluations were made.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.