Cerebral PalsyNCT02490462
Impact of an Education Program for Parents of Children With Cerebral Palsy
A study testing Education + Conventional PhysicalTherapy and Conventional Physical Therapy in people with Cerebral Palsy, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to improving the neuromotor components at the level of structure and body function, must empower them to carry out their activities and daily tasks and enable their social participation. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Education + Conventional PhysicalTherapy and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Dec 2017
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral Palsy diagnosis for children,
- Children will be included presenting grade II, III on Classification System of Gross Motor Function (GMFCS) aged 6 months to 12 years old.
- Parent or caregiver who devote yourself full-time to the child,
- Acceptance of parents for children to participate in the protocol by signing the free and informed consent form.
Who cannot join
- Peripheral nervous system disease or brain stem
- Children with other chronic diseases receiving palliative care,
- Children who present bone deformity and scoliosis structured Cobb > 30 and lower limb deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Physical Therapy Associated With a Program of Education of Caregivers in Functioning and Quality of Life of Children With Cerebral Palsy
The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to improving the neuromotor components at the level of structure and body function, must empower them to carry out their activities and daily tasks and enable their social participation. In this way, the goals of Physical Therapy are related to promote the independence and functionality of the individual in situations of daily life. The participation of caregivers in the rehabilitation process can contribute to potentiate the gains obtained by physical therapy as well as to which they are incorporated into the day to day management of children with cerebral palsy. Objective: To assess whether Physical Therapy associated with the education of caregivers is effective in improving the functioning and quality of life of children with cerebral palsy. Hypothesis: The combination of Physical therapy with the education of caregivers improves in 15% the parameters analyzed against only 10% in those who are only Physical Therapy. Methods: 60 children with cerebral palsy after acceptance and signature in the term of informed consent will be randomly divided into 2 groups (G1: Physiotherapy and education of caregivers and G2: only Physical Therapy) to do 3 sessions of Physical Therapy and 1 weekly session of group education with duration of 45 min during 12 consecutive weeks. The evaluation will be carried out by means of the System of Classification of Motor Function Gross (GMFCS), the evaluation of Motor Function through the scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and Participation will be evaluated by the Inventory of Evaluation of Pediatric Disability (PEDI). The analysis of the results will be carried out using the Statistical Package for the Social Sciences (SPSS) using descriptive statistics for social and demographic characteristics and inferential for normality of data (test Kolmogorov-Smirnov ), mean comparison test to check for differences between the groups and measures of association through the coefficient of correlation. The level of significance of 5% will be established
Read the detailed description
Randomized clinical trial (RCT) in accordance with the recommendations of the Report of Consolidated Standards Trials (CONSORT) held in Clinical School of Physical Therapy, Federal University of Bahia (UFBA), Salvador, Bahia, with cerebral palsy patients and their caregivers. Selection of the population: Inclusion criteria 's own diagnosis of cerebral palsy for children, children will be included presenting grade I, II, III, IV and V in the System Gross Motor Function Classification (GMFCS) aged 1 year to 12 years old, and a parent or caregiver who dedicate themselves in full-time child, comply with the intervention protocol and sign the free and informed consent (IC). They will be deleted: Patients will be excluded disease of the peripheral nervous system or brain stem, children with other chronic diseases receiving palliative care, and children who have bone deformities such as scoliosis structured Cobb > 30 and lower limb deformity. A sample of 20 patients group is required. The sample size for the study was calculated, considering a statistical power of 80% to 5% alpha. Evaluation procedures: To measurement of motor function were used the Gross Motor Function Measure (GMFM-88) scales . The range consists of 5 sizes and each size is an engine development phase that is related to the first quarters of life. The GMFM-88 with respect to motor development stage presented by the child and the evaluator should assess only the dimensions that represent the stages of engine development for age. To check the Activity and Participation will be used Inventory Pediatric Disability Assessment (ASK). applied in children from 6 months to 7.5 years. It can also be used with older children who have functional limitations with performance below the expected for their age compared to typical children of the normative sample and can be used with children with various types of disabilities.
The ASK can be applied by any member of the interdisciplinary team through interviews with the caretaker. Each item is a task and the ability to realize it is scored as (1) whether the child is able and (0) if it is not able to perform it. Evaluates functional abilities and their performance in the areas of self-care (73 items), mobility (59 items) and social function (65 items).
Measures also the amount of assistance given by the caregiver when performing these tasks and the possible use of adaptations and changes in the environment. In caregiver assistance area for self-care are 8 items, 7 items mobility and social function 5 items. The score ranges from 0 to 5 (total dependence to complete independence).
To investigate the Quality of Life will use the Child Health Questionnaire (CHQ - PF50), in its version for parents, applicable to children through fifteen in health. Each concept has a score of 0-100, with higher scores indicating better health status, satisfaction and well-being, and result in two summary scores - physical and psychosocial (0-70). This questionnaire has been validated for children with cerebral palsy. All these measures will be evaluated in the pre-intervention, 4 weeks, 8 weeks and 12 weeks after initiation of therapy.
Procedure: Using Education will be a protocol for caregivers of children with cerebral palsy for the intervention group, once a week, while children in the control and intervention groups will receive conventional physical therapy twice a week. The established training period will last twelve weeks. Software to create randomization lists (randList®) is used in order to ensure that all individuals have equal chances allocation in groups.
- Conditions
- Cerebral Palsy
- Being tested
- Education + Conventional PhysicalTherapy, Conventional Physical Therapy
- Keywords
- Cerebral Palsy, Physical Therapy, Family-centered Care
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education + Conventional PhysicalTherapyOther
The education program for parents will be held one day a week for 1 hour, with total duration of 12 weeks. During the parents or legal guardian meetings will be oriented to stimulate the drive to your child or ward during everyday activities such as bathing, dressing, eating, transferring, going to the bathroom. Parents will receive a diary to record the activities in the home environment. The orientation day for parents will take place in different days of the day the child will receive physical therapy, so that the physiotherapist responsible for the training of parents is shrouded in relation to the randomization of the subjects. This program will be associated with conventional physical therapy program that provides for movements based on neurodevelopmental concept.
Conventional Physical TherapyOther
The full program will be for 24 weeks, the first step will consist of 12 weeks of training with a frequency of twice a week should total at least 18 Conventional physical therapy interventions and 09 meetings of guidelines for parents. After this step be performed to start new reviews second step further 12 weeks with the same characteristics as the first 12 weeks. The conventional physiotherapy program will consist of functional muscle training focused on the task. Tasks will be individualized based on the results of the evaluations of Gross Motor Function and Inventory Pediatric Evaluation of Disability. The sessions will last 45 minutes carried out 2 times a week, training will have a total duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Education + Conventional PhysicalTherapy | Experimental | Parents of children with cerebral palsy receive instructions for active inclusion of children in everyday activities. The education program for parents will take place once a week for twelve weeks. Children with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks. Receives: Other: Education + Conventional PhysicalTherapy |
| Conventional Physical Therapy | Active comparator | Children with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Functionality
Assess whether the associated physical therapy education of caregivers is effective in improving the functionality of children with cerebral palsy after a 12-week period.
Measured: 12 weeks
Secondary outcomes (4)
Gross Motor Function
To investigate the change in the gross motor function of children with cerebral palsy after physiotherapy intervention associated with an education program for parents.
To measurement of motor function were used the GMFM-88 scales (Gross Motor Function Measure). The scales will be implemented before the start of the intervention and after six months of physiotherapy. The GMFM-88 consists of 88 items organized in five dimensions, the first lying and rolling, Sitting, crawling and Kneeling, Standing, Walking , Running and Jumping . The items are sorted within each dimension according to the practicality of execution within the overall assessment and difficulty. For each item, 0-3 notes are set, and the value 0 corresponds to the inactivity of the child in the requested activity.
Measured: 12 weeks
Improvement in Functionality
Describe the functional profile of children with cerebral palsy according to the International Classification of Functioning.
To check the Activity and Participation will be used Inventory Pediatric Disability Assessment (ASK). This review (25) is designed to be applied to children 6 months old to 7.5 years. It can also be used with older children who have functional limitations with performance below the expected for their age compared to typical children of the normative sample and can be used with children with various types of disabilities.
The ASK can be applied by any member of the interdisciplinary team through interviews with the caretaker. Each item is a task and the ability to realize it is scored as (1) whether the child is able and (0) if it is not able to perform it. Evaluates functional abilities and their performance in the areas of self-care (73 items), mobility (59 items) and social function (65 items).
Measured: 12 weeks
Motor performance and functional
To estimate the correlation engine and functional performance in children with cerebral palsy. It will be used the correlation test of Pearson or Spearman depending on the normality of the data, with information regarding the motor function and functionality.
Measured: 12 weeks
Frequency of exercises
To investigate the influence of the regularity of carrying out household activities on the Gross Motor Function, Activity and Participation and Quality of life in children with cerebral palsy through a daily exercise.
To assess the frequency of carrying out the activities, parents will receive a weekly diary with daily activities arranged in rows and days and shifts the willing week column. Should mark the days and corresponding shifts stimulation that performed in each functional activity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansueto Gomes Neto, Federal University of Bahia
- Investigators
- Manseuto Gomes Neto, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490462
- Sponsor's protocol ID
- FUBahia060278
- Status last verified
- Aug 2017
- First submitted
- 6 May 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Therapy Associated With a Program of Education of Caregivers in Functioning and Quality of Life of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02490462
- Acronym / sponsor ID
- FUBahia060278
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Physical Therapy, Family-centered Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- 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.
The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to improving the neuromotor components at the level of structure and body function, must empower them to carry out their activities and daily tasks and enable their social participation. In this way, the goals of Physical Therapy are related to promote the independence and functionality of the individual in situations of daily life. The participation of caregivers in the rehabilitation process can contribute to potentiate the gains obtained by physical therapy as well as to which they are incorporated into the day to day management of children with cerebral palsy. Objective: To assess whether Physical Therapy associated with the education of caregivers is effective in improving the functioning and quality of life of children with cerebral palsy. Hypothesis: The combination of Physical therapy with the education of caregivers improves in 15% the parameters analyzed against only 10% in those who are only Physical Therapy. Methods: 60 children with cerebral palsy after acceptance and signature in the term of informed consent will be randomly divided into 2 groups (G1: Physiotherapy and education of caregivers and G2: only Physical Therapy) to do 3 sessions of Physical Therapy and 1 weekly session of group education with duration of 45 min during 12 consecutive weeks. The evaluation will be carried out by means of the System of Classification of Motor Function Gross (GMFCS), the evaluation of Motor Function through the scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and Participation will be evaluated by the Inventory of Evaluation of Pediatric Disability (PEDI). The analysis of the results will be carried out using the Statistical Package for the Social Sciences (SPSS) using descriptive statistics for social and demographic characteristics and inferential for normality of data (test Kolmogorov-Smirnov ), mean comparison test to check for differences between the groups and measures of association through the coefficient of correlation. The level of significance of 5% will be established
Detailed description
Randomized clinical trial (RCT) in accordance with the recommendations of the Report of Consolidated Standards Trials (CONSORT) held in Clinical School of Physical Therapy, Federal University of Bahia (UFBA), Salvador, Bahia, with cerebral palsy patients and their caregivers. Selection of the population: Inclusion criteria 's own diagnosis of cerebral palsy for children, children will be included presenting grade I, II, III, IV and V in the System Gross Motor Function Classification (GMFCS) aged 1 year to 12 years old, and a parent or caregiver who dedicate themselves in full-time child, comply with the intervention protocol and sign the free and informed consent (IC). They will be deleted: Patients will be excluded disease of the peripheral nervous system or brain stem, children with other chronic diseases receiving palliative care, and children who have bone deformities such as scoliosis structured Cobb > 30 and lower limb deformity. A sample of 20 patients group is required. The sample size for the study was calculated, considering a statistical power of 80% to 5% alpha. Evaluation procedures: To measurement of motor function were used the Gross Motor Function Measure (GMFM-88) scales . The range consists of 5 sizes and each size is an engine development phase that is related to the first quarters of life. The GMFM-88 with respect to motor development stage presented by the child and the evaluator should assess only the dimensions that represent the stages of engine development for age. To check the Activity and Participation will be used Inventory Pediatric Disability Assessment (ASK). applied in children from 6 months to 7.5 years. It can also be used with older children who have functional limitations with performance below the expected for their age compared to typical children of the normative sample and can be used with children with various types of disabilities.
The ASK can be applied by any member of the interdisciplinary team through interviews with the caretaker. Each item is a task and the ability to realize it is scored as (1) whether the child is able and (0) if it is not able to perform it. Evaluates functional abilities and their performance in the areas of self-care (73 items), mobility (59 items) and social function (65 items).
Measures also the amount of assistance given by the caregiver when performing these tasks and the possible use of adaptations and changes in the environment. In caregiver assistance area for self-care are 8 items, 7 items mobility and social function 5 items. The score ranges from 0 to 5 (total dependence to complete independence).
To investigate the Quality of Life will use the Child Health Questionnaire (CHQ - PF50), in its version for parents, applicable to children through fifteen in health. Each concept has a score of 0-100, with higher scores indicating better health status, satisfaction and well-being, and result in two summary scores - physical and psychosocial (0-70). This questionnaire has been validated for children with cerebral palsy. All these measures will be evaluated in the pre-intervention, 4 weeks, 8 weeks and 12 weeks after initiation of therapy.
Procedure: Using Education will be a protocol for caregivers of children with cerebral palsy for the intervention group, once a week, while children in the control and intervention groups will receive conventional physical therapy twice a week. The established training period will last twelve weeks. Software to create randomization lists (randList®) is used in order to ensure that all individuals have equal chances allocation in groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education + Conventional PhysicalTherapy | Experimental | Other: Education + Conventional PhysicalTherapyParents of children with cerebral palsy receive instructions for active inclusion of children in everyday activities. The education program for parents will take place once a week for twelve weeks. Children with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks. |
| Conventional Physical Therapy | Active comparator | Other: Conventional Physical TherapyChildren with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cerebral Palsy diagnosis for children,
- Children will be included presenting grade II, III on Classification System of Gross Motor Function (GMFCS) aged 6 months to 12 years old.
- Parent or caregiver who devote yourself full-time to the child,
- Acceptance of parents for children to participate in the protocol by signing the free and informed consent form.
Key exclusion criteria (3 listed)
- Peripheral nervous system disease or brain stem
- Children with other chronic diseases receiving palliative care,
- Children who present bone deformity and scoliosis structured Cobb > 30 and lower limb deformity.
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 |
|---|---|---|
| Education + Conventional PhysicalTherapyThe education program for parents will be held one day a week for 1 hour, with total duration of 12 weeks. During the parents or legal guardian meetings will be oriented to stimulate the drive to your child or ward during everyday activities such as bathing, dressing, eating, transferring, going to the bathroom. Parents will receive a diary to record the activities in the home environment. The orientation day for parents will take place in different days of the day the child will receive physical therapy, so that the physiotherapist responsible for the training of parents is shrouded in relation to the randomization of the subjects. This program will be associated with conventional physical therapy program that provides for movements based on neurodevelopmental concept. | Other | Education + Conventional PhysicalTherapy |
| Conventional Physical TherapyThe full program will be for 24 weeks, the first step will consist of 12 weeks of training with a frequency of twice a week should total at least 18 Conventional physical therapy interventions and 09 meetings of guidelines for parents. After this step be performed to start new reviews second step further 12 weeks with the same characteristics as the first 12 weeks. The conventional physiotherapy program will consist of functional muscle training focused on the task. Tasks will be individualized based on the results of the evaluations of Gross Motor Function and Inventory Pediatric Evaluation of Disability. The sessions will last 45 minutes carried out 2 times a week, training will have a total duration of 12 weeks. | Other | Conventional Physical Therapy |
Primary outcome
Improvement in Functionality
Time frame: 12 weeks
Assess whether the associated physical therapy education of caregivers is effective in improving the functionality of children with cerebral palsy after a 12-week period.
4 secondary outcomes
Gross Motor Function
Time frame: 12 weeks
Improvement in Functionality
Time frame: 12 weeks
Motor performance and functional
Time frame: 12 weeks
Frequency of exercises
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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.
Manseuto Gomes Neto principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education + Conventional PhysicalTherapy and Conventional Physical Therapy in people with Cerebral Palsy, run by Federal University of Bahia at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. 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 Brazil. 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?
Results are not available in the source record.
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?
Improvement in Functionality (time frame: 12 weeks). 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 11 Aug 2017.