Cerebral PalsyNCT05505149
Prognosis of Functionality in Cerebral Palsy: A Retrospektif Study
A study testing physiotherapy in people with Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
To purpose of this study is ;to evaluate prognosis of functionality in children with Cerebral Palsy in different age groups (preschool, school age and adolescence) and predict the progression of motor function according to different functional classification systems in children with CP over a 2 year period. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Feb 2022
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- being aged between 0-18 years old,
- being diagnosed with spastic type CP.
Who cannot join
- having botulinum toxin injection
- having orthopedic surgery
- having epileptic seizures.
Trial locations and contacts
1 site in 1 country.
About this study
To purpose of this study is ;to evaluate prognosis of functionality in children with Cerebral Palsy in different age groups (preschool, school age and adolescence) and predict the progression of motor function according to different functional classification systems in children with CP over a 2 year period.
Read the detailed description
Cerebral Palsy (CP) is defined as 'a group of persistent, non-progressive, postural and movement disorders that occur in the developing fetal or infant brain, causing activity limitation'. The European Cerebral Palsy Monitoring Group has divided CP into 3 classes as spastic, dyskinetic and ataxic types. Spastic type is divided into two as unilateral spastic type SP, where one half of the body is affected, and bilateral spastic type SP, where both halves of the body are affected. Researchers and clinicians typically group individuals with CP using descriptive classification systems according to the types of tone disorders, the distribution of motor deficits, or the level of independence. However, motor disorders in children with CP are often accompanied by sensory, perception, cognitive, communication, behavior and secondary musculoskeletal problems and epilepsy. In addition to impaired muscle tone, postural control and synergistic muscle activation in both proximal and distal body parts, muscle and joint contractures are observed as a result of muscle weakness, decreased exercise tolerance and limitation in functional activities. Since CP is an umbrella term that includes developmental problems in addition to motor disorders, many developmental areas should be evaluated. According to the World Health Organization's International Classification of Functioning, Disability and Health, the health status of the individual; should be evaluated in a holistic perspective, which includes the definition and evaluation of functions such as eating, drinking, dexterity, communication and mobility. The functional status of children with CP in different developmental areas is determined by developmental area-specific classification systems. The classification system is used to classify and categorize. Functional classifications in CP are used to facilitate communication between clinicians, to create homogeneous groups in clinical studies, and to customize the treatment and follow-up of the patient according to the individual. Determining the current functional status of children with CP with classification systems contributes to making predictions about the quality of life and functional status of the child and family. In addition, predictions about changes in gross motor functions of children with CP are helpful in developing programs to prepare children for adolescence and adulthood. Because the stability of the system that classifies gross motor skills is still unclear, especially in adolescence. Determining the stability of the system that classifies gross motor skills in children with CP during their transition to adulthood will be critical in determining the prognosis of motor functions in adolescence. In children with CP, hand functions are restricted at different levels according to the extremity involvement affected by spasticity. Since the lower extremity involvement of the child with spastic diparetic CP is more, bimanual hand skills can be better classified. A child with quadriparetic CP may have limited hand skills since all four extremities are involved. For this reason, we think that determining the stability and progression of the manual skills classification systems in the rehabilitation process is important in terms of evaluating the success of the rehabilitation and the development of the child's participation in activities of daily living, eating and drinking functions.
Cognitive disorders may accompany motor skills disorders in children with CP. In the study of Unes et al., which included 225 children with CP, it was reported that cognitive skills were impaired in 45% of children, and this could negatively affect their communication skills. In the literature, gross motor functions of individuals with CP 'Gross Motor Function Classification System (GMFCS)', hand skills 'Manual Ability Classification System (MACS)', communication skills 'Communication Function Classification System (CFCS)', eating and drinking skills 'Eating and Drinking Ability Classification System (EDACS)'.
To reveal the functional status of children with CP in different age groups (preschool, school age and adolescence); We think that it will evaluate the child holistically, provide information about the future functional level of the child, and help shape the existing treatment programs according to different age groups.
The design of this study is a retrospective cohort study. Children with spastic type Cerebral Palsy between the ages of 0 and 18 who received physiotherapy at Ereğli Private Gökkuşağı Special Education and Rehabilitation Center and Düzce Private Gökkuşağı Special Education and Rehabilitation Center were included. Functionality of 108 children with spastic type Cerebral Palsy was evaluated by the researcher (S.A.T) over two years. The children participated in the physiotherapy program, during 45 minutes two times for a week over two years. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. The children were divided into 3 groups according to their age: 0-6 (preschool), 7-12 (school age), 13-18 (adolescent). The first evaluation was made in February 2020 and the last evaluation was made twice, in February 2022. After the demographic characteristics of the children (age, gender, CP type) were taken, their functionalities were 'Gross Motor Function Classification System (KMFSS)', 'Manual Ability Classification System (MACS)', 'Communication Function Classification System (CFCS)' and 'Eating and Drinking Ability Classification'. System (EDACS)' was classified.
The eligibility criteria were as follows: (1) being aged between 0-18 years old, (2) being diagnosed with spastic type CP. The exclusion criteria were as follows: (1) having botulinum toxin injection; (2) having orthopedic surgery; (3) having epileptic seizures.
The sample size and power calculation were performed using the G*Power 3.1 power analysis program. The calculations were based on an odds ratio of 1.9 (calculated from the pilot study), an alpha level of 0.05, and the desired power of 80%. These parameters generate a necessary sample size of at least 101. To allow for dropouts, 125 children with CP were invited to study.
Statistical Package for Social Science (SPSS) version 21.0 for Windows software (SPSS, Inc., Chicago, IL, USA) was used for all statistical analyses. Before the statistical analysis, the Kolmogorov-Smirnov test was used to assess the data's distribution. Descriptive statistics, including frequency, the percentage for nominal variables, and mean and standard deviation for continuous variables were calculated. "Binary Logistic Regression Analysis" was used in the analysis of the model testing whether children with CP's age, sex, type of CP, Gross Motor Function Classification System level, Manual Ability Classification System level, Communication Function Classification System level, Eating and Drinking Ability Classification System level predict improvement in Gross Motor Function Classification System level (yes or no) after physiotherapy. The Enter method was used, and the Hosmer-Lemeshow (H-L) test was done for assessing the goodness of fit of the fitted logistic regression model. The results were evaluated by considering the model fit statistics and parameter significance and the significance level was set at p<0.05.
- Conditions
- Cerebral Palsy
- Being tested
- physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers.
| Study group | Role | What they receive |
|---|---|---|
| 0 to 6 years old spastic cerebral palsy | Active comparator | Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. Receives: Other: physiotherapy |
| 7 to 12 years old spastic cerebral palsy | Active comparator | Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. Receives: Other: physiotherapy |
| 13 to 18 years old spastic cerebral palsy | Active comparator | Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System (GMFCS)
The GMFCS is a system that classifies the gross motor functions of the child with CP. This system includes five levels: 1 (most independent) to level 5 (fully dependent).
Measured: two years
Secondary outcomes (3)
Manual Ability Classification System (MACS)
The MACS is a classification system developed to classify manual skills for children with CP aged 4-18. This system includes five levels: 1 (most independent) to level 5 (fully dependent). In this study, Mini MACS was also used to classify the hand skills of children aged 0-4.
Measured: two years
Communication Function Classification System (CFCS)
The CFCS is a valid and reliable system that classifies the communication skills of children with CP at the level of activity and participation. This system includes five levels: 1 (most independent) to level 5 (fully dependent).
Measured: two years
Eating and Drinking Ability Classification System (EDACS)
The EDACS is used for classify the eating and drinking skills of children with CP. This system includes five levels: 1 (most independent) to level 5 (fully dependent)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Feb 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Preschool age group, school age group, adolescent age group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Seda AYAZ TAŞ, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505149
- Sponsor's protocol ID
- BAIBU - SAT2
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Functionality in Cerebral Palsy: A Retrospektif Study
- ClinicalTrials.gov ID
- NCT05505149
- Acronym / sponsor ID
- BAIBU - SAT2
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 Aug 2022 (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.
To purpose of this study is ;to evaluate prognosis of functionality in children with Cerebral Palsy in different age groups (preschool, school age and adolescence) and predict the progression of motor function according to different functional classification systems in children with CP over a 2 year period.
Detailed description
Cerebral Palsy (CP) is defined as 'a group of persistent, non-progressive, postural and movement disorders that occur in the developing fetal or infant brain, causing activity limitation'. The European Cerebral Palsy Monitoring Group has divided CP into 3 classes as spastic, dyskinetic and ataxic types. Spastic type is divided into two as unilateral spastic type SP, where one half of the body is affected, and bilateral spastic type SP, where both halves of the body are affected. Researchers and clinicians typically group individuals with CP using descriptive classification systems according to the types of tone disorders, the distribution of motor deficits, or the level of independence. However, motor disorders in children with CP are often accompanied by sensory, perception, cognitive, communication, behavior and secondary musculoskeletal problems and epilepsy. In addition to impaired muscle tone, postural control and synergistic muscle activation in both proximal and distal body parts, muscle and joint contractures are observed as a result of muscle weakness, decreased exercise tolerance and limitation in functional activities. Since CP is an umbrella term that includes developmental problems in addition to motor disorders, many developmental areas should be evaluated. According to the World Health Organization's International Classification of Functioning, Disability and Health, the health status of the individual; should be evaluated in a holistic perspective, which includes the definition and evaluation of functions such as eating, drinking, dexterity, communication and mobility. The functional status of children with CP in different developmental areas is determined by developmental area-specific classification systems. The classification system is used to classify and categorize. Functional classifications in CP are used to facilitate communication between clinicians, to create homogeneous groups in clinical studies, and to customize the treatment and follow-up of the patient according to the individual. Determining the current functional status of children with CP with classification systems contributes to making predictions about the quality of life and functional status of the child and family. In addition, predictions about changes in gross motor functions of children with CP are helpful in developing programs to prepare children for adolescence and adulthood. Because the stability of the system that classifies gross motor skills is still unclear, especially in adolescence. Determining the stability of the system that classifies gross motor skills in children with CP during their transition to adulthood will be critical in determining the prognosis of motor functions in adolescence. In children with CP, hand functions are restricted at different levels according to the extremity involvement affected by spasticity. Since the lower extremity involvement of the child with spastic diparetic CP is more, bimanual hand skills can be better classified. A child with quadriparetic CP may have limited hand skills since all four extremities are involved. For this reason, we think that determining the stability and progression of the manual skills classification systems in the rehabilitation process is important in terms of evaluating the success of the rehabilitation and the development of the child's participation in activities of daily living, eating and drinking functions.
Cognitive disorders may accompany motor skills disorders in children with CP. In the study of Unes et al., which included 225 children with CP, it was reported that cognitive skills were impaired in 45% of children, and this could negatively affect their communication skills. In the literature, gross motor functions of individuals with CP 'Gross Motor Function Classification System (GMFCS)', hand skills 'Manual Ability Classification System (MACS)', communication skills 'Communication Function Classification System (CFCS)', eating and drinking skills 'Eating and Drinking Ability Classification System (EDACS)'.
To reveal the functional status of children with CP in different age groups (preschool, school age and adolescence); We think that it will evaluate the child holistically, provide information about the future functional level of the child, and help shape the existing treatment programs according to different age groups.
The design of this study is a retrospective cohort study. Children with spastic type Cerebral Palsy between the ages of 0 and 18 who received physiotherapy at Ereğli Private Gökkuşağı Special Education and Rehabilitation Center and Düzce Private Gökkuşağı Special Education and Rehabilitation Center were included. Functionality of 108 children with spastic type Cerebral Palsy was evaluated by the researcher (S.A.T) over two years. The children participated in the physiotherapy program, during 45 minutes two times for a week over two years. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. The children were divided into 3 groups according to their age: 0-6 (preschool), 7-12 (school age), 13-18 (adolescent). The first evaluation was made in February 2020 and the last evaluation was made twice, in February 2022. After the demographic characteristics of the children (age, gender, CP type) were taken, their functionalities were 'Gross Motor Function Classification System (KMFSS)', 'Manual Ability Classification System (MACS)', 'Communication Function Classification System (CFCS)' and 'Eating and Drinking Ability Classification'. System (EDACS)' was classified.
The eligibility criteria were as follows: (1) being aged between 0-18 years old, (2) being diagnosed with spastic type CP. The exclusion criteria were as follows: (1) having botulinum toxin injection; (2) having orthopedic surgery; (3) having epileptic seizures.
The sample size and power calculation were performed using the G*Power 3.1 power analysis program. The calculations were based on an odds ratio of 1.9 (calculated from the pilot study), an alpha level of 0.05, and the desired power of 80%. These parameters generate a necessary sample size of at least 101. To allow for dropouts, 125 children with CP were invited to study.
Statistical Package for Social Science (SPSS) version 21.0 for Windows software (SPSS, Inc., Chicago, IL, USA) was used for all statistical analyses. Before the statistical analysis, the Kolmogorov-Smirnov test was used to assess the data's distribution. Descriptive statistics, including frequency, the percentage for nominal variables, and mean and standard deviation for continuous variables were calculated. "Binary Logistic Regression Analysis" was used in the analysis of the model testing whether children with CP's age, sex, type of CP, Gross Motor Function Classification System level, Manual Ability Classification System level, Communication Function Classification System level, Eating and Drinking Ability Classification System level predict improvement in Gross Motor Function Classification System level (yes or no) after physiotherapy. The Enter method was used, and the Hosmer-Lemeshow (H-L) test was done for assessing the goodness of fit of the fitted logistic regression model. The results were evaluated by considering the model fit statistics and parameter significance and the significance level was set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Preschool age group, school age group, adolescent age group
| Arm | Type | Receives |
|---|---|---|
| 0 to 6 years old spastic cerebral palsy | Active comparator | Other: physiotherapyChildren were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. |
| 7 to 12 years old spastic cerebral palsy | Active comparator | Other: physiotherapyChildren were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. |
| 13 to 18 years old spastic cerebral palsy | Active comparator | Other: physiotherapyChildren were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- being aged between 0-18 years old,
- being diagnosed with spastic type CP.
Key exclusion criteria (3 listed)
- having botulinum toxin injection
- having orthopedic surgery
- having epileptic seizures.
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 |
|---|---|---|
| physiotherapyChildren were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers. | Other | 0 to 6 years old spastic cerebral palsy, 13 to 18 years old spastic cerebral palsy, 7 to 12 years old spastic cerebral palsy |
Primary outcome
Gross Motor Function Classification System (GMFCS)
Time frame: two years
The GMFCS is a system that classifies the gross motor functions of the child with CP. This system includes five levels: 1 (most independent) to level 5 (fully dependent).
3 secondary outcomes
Manual Ability Classification System (MACS)
Time frame: two years
Communication Function Classification System (CFCS)
Time frame: two years
Eating and Drinking Ability Classification System (EDACS)
Time frame: two years
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 17 Aug 2022.
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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.
Seda AYAZ TAŞ principal investigator
Abant Izzet Baysal 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 physiotherapy in people with Cerebral Palsy, run by Abant Izzet Baysal University 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 2 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 17 Aug 2022. 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?
Gross Motor Function Classification System (GMFCS) (time frame: two years). 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 17 Aug 2022.