Cerebral PalsyNCT04614207
Cerebral Palsy & Predictors of Physical Activity
An observational study of Cerebral Palsy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Children and adolescents with cerebral palsy may be trapped in a vicious circle of low physical fitness, early fatigue in daily activities, resulting in deconditioning and a further decrease in physical activity. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 123 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2020to 31 Jan 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 8 to 15 years
- All sexes
- Child
Study population: All children and adolescents between the ages of 8 and 15 years, diagnosed with cerebral palsy in Denmark. The study population will be selected thru the Danish Health Data Authority ('Sundhedsdatastyrelsen') where social security numbers of parents/guardians sharing an adresse with an individual from the study population, will be used as a means of contact.
Who may be able to join
- Children born in the timeperiod 2003 - 2013
- Diagnosed with cerebral palsy (according to current classifications)
- Gross Motor Function Classification System (GMFCS) level I - III
- Registered in the Cerebral Palsy Follow-up Registry (CPUP), Denmark (As explained in the Statistical Analysis Plan dated June 6, 2022, CPUP data will be used were available. However, being registred in the CPUP database is no longer a requirement).
Who cannot join
- Parents/guardians unable to read and understand Danish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Physical Activity Levels in Children and Adolescents With Cerebral Palsy - a Clinical Cohort Study
Children and adolescents with cerebral palsy may be trapped in a vicious circle of low physical fitness, early fatigue in daily activities, resulting in deconditioning and a further decrease in physical activity. From this perspective, establishing a healthy and active lifestyle during childhood is even more important for individuals with a disability, who are at higher risk for functional limitations and general fatigue in addition with developing secondary' conditions such as cardiovascular disease, diabetes, and obesity. Furthermore, physical activity has a positive impact on quality of life, but it remains unknown which factors that influence high levels of habitual physical activity in children and adolescents with cerebral palsy.
The present research project will investigate predictors of habitual physical activity in children and adolescents with cerebral palsy with the perspective of providing evidence on optimizing physical activity and consequently improved overall health.
Read the detailed description
Cerebral palsy (CP) is a condition that describes a group of disorders (altered muscle tone, movements disorder, muscle weakness, ataxia and rigidity) covering the development of movement and posture causing activity limitations and reduced quality of life (1). In Denmark 2000-2500 children and adolescents under the age of 18 are living with the diagnosis of cerebral palsy. This is equivalent to two children being diagnosed with cerebral palsy per 1000 living births (2). Though, CP is a non-progressive diagnosis, it is a lifelong condition that requires attention through most of the patient's life, as impairments that inhibit performance of activities and participation in daily living develops (1, 3). Children and adolescents with cerebral palsy are a vulnerable group who find it challenging to meet the physical activity guidelines, therefore predisposing them to the negative health implications associated with low levels of physical activity and high levels of sedentary time (4).
Although there are no specific evidence-based physical activity guidelines for children and adolescents with cerebral palsy, it is clear that they have lower levels of physical activity than their peers, that they do not meet the World Health Organization's physical activity guidelines, and that their level of mobility limitation is negatively associated with their level of physical activity (5, 6).
Therefore, the objective of this study is to investigate predictors of physical activity and inactivity in children and adolescents with cerebral palsy with the perspective of providing evidence-based motivators for optimized physical activity, with the potential benefit of improved overall health and quality of life.
This is a prospective clinical cohort study. Eligible children and adolescents and their families will be identified through the Danish Health Data Authority after which the parents/guardians will receive written information about the study through digital post, e-Boks.
Parents/guardians will be asked to fill out questionnaires on quality of life, overall health, pain and participation in normal daily activities, and the children/adolescents will be asked to wear accelerometers for seven consecutive days. Data from the Cerebral Palsy FollowUp Program (CPUP) register will be collected.
The project will be implemented in accordance with the Helsinki Declaration II. It has been approved by the Danish Data protection Agency and has been declared not notifiable by the Regional Committee on Health Research Ethics, cf. Committee Act Art. 14, paragraph 1 (S-20192000-23). All subject data will be treated confidentially and in confidence under the Danish laws on personal data and health.
This study will provide novel evidence that will improve the knowledge on how to optimize physical activity, and thus improve overall health and quality of life, for the current group of children and adolescents. Due to wide inclusion criteria, this knowledge will constitute a high level of generalizability and most probably high acceptance by the treating health professionals as the majority of variables of interest already are implemented in a current cerebral palsy registry. Finally, the findings may be implemented in evidence-based physical activity guidelines, which currently are lacking for the present group of children and adolescents with cerebral palsy.
- Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet (London, England). 2004;363(9421):1619-31.
- Frøslev-Friis C, Dunkhase-Heinl U, Andersen JD, Stausbøl-Grøn B, Hansen AV, Garne E. Epidemiology of cerebral palsy in Southern Denmark. Danish medical journal. 2015;62(1):A4990.
- Bell KJ, Ounpuu S, DeLuca PA, Romness MJ. Natural progression of gait in children with cerebral palsy. J Pediatr Orthop. 2002;22(5):677-82.
- Organization WHO. Global recommendations for physical activity for health. Switzerland2010.
- Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disability and rehabilitation. 2013;35(8):647-55.
- Bjornson KF, Belza B, Kartin D, Logsdon R, McLaughlin JF. Ambulatory physical activity performance in youth with cerebral palsy and youth who are developing typically. Phys Ther. 2007;87(3):248-57.
- Conditions
- Cerebral Palsy
- Keywords
- Physical activity, Accelerometry, Quality of life, Children, Adolescents
- Medical subject headings
- Cerebral Palsy, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Model 1a: Prediction of habitual physical activity using data from the CPUP registry
Habitual physical activity will be assessed objectively using accelerometer counts.
Multiple linear regression analyzes between accelerometer counts (response variable) and all CPUP variables within each ICF (International Classification of Functioning, Disability and Health) component as predictive variables, using the latest CPUP registration prior to accelerometer data collection.
Measured: Response variable is measured between 0 and 39 months post registry data (predictive variables).
Secondary outcomes (3)
Model 1b: Prediction of habitual physical activity using data from questionnaire variables
Habitual physical activity will be assessed objectively using accelerometer counts.
Multiple linear regression analysis between accelerometer counts (response variable) and all questionnaire variables within each ICF component (predictive variables), using the questionnaire data.
Measured: Response variable is measured between 1 and 15 months post registry data (predictive variables).
Model 2a: Prediction of habitual physical activity using data from the CPUP registry (penalized regression)
Penalized regression (lasso) with accelerometer counts as the response variable and covariates as chosen by lasso to obtain an optimal fit from model 1a as predictive variables to determine which variables to retain in the model.
Measured: Response variable is measured between 0 and 39 months post registry data (predictive variables).
Model 2b: Prediction of habitual physical activity using data from questionnaire variables (penalized regression)
Penalized regression (lasso) with accelerometer counts as the response variable and covariates as chosen by lasso to obtain an optimal fit from model 1b as predictive variables to determine which variables to retain in the model.
Measured: Accelerometer data is collected 1-15 months post collection of questionnaire data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start3 Nov 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Elsass Foundation, Region of Southern Denmark, AJ Andersen og Hustrus Fond, The Hede Nielsen Family Foundation, Dagmar Marshalls Fond, Fonden til Lægevidenskabens Fremme
- Responsible party
- Sponsor
- Investigators
- Anders Holsgaard-Larsen, Assoc. Prof, Study director, Department of Clinical Research, University of Southern Denmark.Christina E Fonvig, MSc, Principal investigator, Department of Clinical Research, University of Southern Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614207
- Sponsor's protocol ID
- 1-Fonvig
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2020
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on sex, birth date, and cerebral palsy classification among other. Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.
Publications
Fonvig CE, Troelsen J, Dunkhase-Heinl U, Lauritsen JM, Holsgaard-Larsen A. Predictors of physical activity levels in children and adolescents with cerebral palsy: clinical cohort study protocol. BMJ Open. 2021 Sep 21;11(9):e047522. doi: 10.1136/bmjopen-2020-047522.
PubMed 34548350
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Physical Activity Levels in Children and Adolescents With Cerebral Palsy - a Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT04614207
- Acronym / sponsor ID
- 1-Fonvig
- Conditions
- Cerebral Palsy
- Keywords
- Physical activity, Accelerometry, Quality of life, Children, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Elsass Foundation, Region of Southern Denmark, AJ Andersen og Hustrus Fond, The Hede Nielsen Family Foundation, Dagmar Marshalls Fond, Fonden til Lægevidenskabens Fremme
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 3 Nov 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.
Children and adolescents with cerebral palsy may be trapped in a vicious circle of low physical fitness, early fatigue in daily activities, resulting in deconditioning and a further decrease in physical activity. From this perspective, establishing a healthy and active lifestyle during childhood is even more important for individuals with a disability, who are at higher risk for functional limitations and general fatigue in addition with developing secondary' conditions such as cardiovascular disease, diabetes, and obesity. Furthermore, physical activity has a positive impact on quality of life, but it remains unknown which factors that influence high levels of habitual physical activity in children and adolescents with cerebral palsy.
The present research project will investigate predictors of habitual physical activity in children and adolescents with cerebral palsy with the perspective of providing evidence on optimizing physical activity and consequently improved overall health.
Detailed description
Cerebral palsy (CP) is a condition that describes a group of disorders (altered muscle tone, movements disorder, muscle weakness, ataxia and rigidity) covering the development of movement and posture causing activity limitations and reduced quality of life (1). In Denmark 2000-2500 children and adolescents under the age of 18 are living with the diagnosis of cerebral palsy. This is equivalent to two children being diagnosed with cerebral palsy per 1000 living births (2). Though, CP is a non-progressive diagnosis, it is a lifelong condition that requires attention through most of the patient's life, as impairments that inhibit performance of activities and participation in daily living develops (1, 3). Children and adolescents with cerebral palsy are a vulnerable group who find it challenging to meet the physical activity guidelines, therefore predisposing them to the negative health implications associated with low levels of physical activity and high levels of sedentary time (4).
Although there are no specific evidence-based physical activity guidelines for children and adolescents with cerebral palsy, it is clear that they have lower levels of physical activity than their peers, that they do not meet the World Health Organization's physical activity guidelines, and that their level of mobility limitation is negatively associated with their level of physical activity (5, 6).
Therefore, the objective of this study is to investigate predictors of physical activity and inactivity in children and adolescents with cerebral palsy with the perspective of providing evidence-based motivators for optimized physical activity, with the potential benefit of improved overall health and quality of life.
This is a prospective clinical cohort study. Eligible children and adolescents and their families will be identified through the Danish Health Data Authority after which the parents/guardians will receive written information about the study through digital post, e-Boks.
Parents/guardians will be asked to fill out questionnaires on quality of life, overall health, pain and participation in normal daily activities, and the children/adolescents will be asked to wear accelerometers for seven consecutive days. Data from the Cerebral Palsy FollowUp Program (CPUP) register will be collected.
The project will be implemented in accordance with the Helsinki Declaration II. It has been approved by the Danish Data protection Agency and has been declared not notifiable by the Regional Committee on Health Research Ethics, cf. Committee Act Art. 14, paragraph 1 (S-20192000-23). All subject data will be treated confidentially and in confidence under the Danish laws on personal data and health.
This study will provide novel evidence that will improve the knowledge on how to optimize physical activity, and thus improve overall health and quality of life, for the current group of children and adolescents. Due to wide inclusion criteria, this knowledge will constitute a high level of generalizability and most probably high acceptance by the treating health professionals as the majority of variables of interest already are implemented in a current cerebral palsy registry. Finally, the findings may be implemented in evidence-based physical activity guidelines, which currently are lacking for the present group of children and adolescents with cerebral palsy.
- Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet (London, England). 2004;363(9421):1619-31.
- Frøslev-Friis C, Dunkhase-Heinl U, Andersen JD, Stausbøl-Grøn B, Hansen AV, Garne E. Epidemiology of cerebral palsy in Southern Denmark. Danish medical journal. 2015;62(1):A4990.
- Bell KJ, Ounpuu S, DeLuca PA, Romness MJ. Natural progression of gait in children with cerebral palsy. J Pediatr Orthop. 2002;22(5):677-82.
- Organization WHO. Global recommendations for physical activity for health. Switzerland2010.
- Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disability and rehabilitation. 2013;35(8):647-55.
- Bjornson KF, Belza B, Kartin D, Logsdon R, McLaughlin JF. Ambulatory physical activity performance in youth with cerebral palsy and youth who are developing typically. Phys Ther. 2007;87(3):248-57.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- All children and adolescents between the ages of 8 and 15 years, diagnosed with cerebral palsy in Denmark. The study population will be selected thru the Danish Health Data Authority ('Sundhedsdatastyrelsen') where social security numbers of parents/guardians sharing an adresse with an individual from the study population, will be used as a means of contact.
Key inclusion criteria (4 listed)
- Children born in the timeperiod 2003 - 2013
- Diagnosed with cerebral palsy (according to current classifications)
- Gross Motor Function Classification System (GMFCS) level I - III
- Registered in the Cerebral Palsy Follow-up Registry (CPUP), Denmark (As explained in the Statistical Analysis Plan dated June 6, 2022, CPUP data will be used were available. However, being registred in the CPUP database is no longer a requirement).
Key exclusion criteria (1 listed)
- Parents/guardians unable to read and understand Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Model 1a: Prediction of habitual physical activity using data from the CPUP registry
Time frame: Response variable is measured between 0 and 39 months post registry data (predictive variables).
Habitual physical activity will be assessed objectively using accelerometer counts. Multiple linear regression analyzes between accelerometer counts (response variable) and all CPUP variables within each ICF (International Classification of Functioning, Disability and Health) component as predictive variables, using the latest CPUP registration prior to accelerometer data collection.
3 secondary outcomes
Model 1b: Prediction of habitual physical activity using data from questionnaire variables
Time frame: Response variable is measured between 1 and 15 months post registry data (predictive variables).
Model 2a: Prediction of habitual physical activity using data from the CPUP registry (penalized regression)
Time frame: Response variable is measured between 0 and 39 months post registry data (predictive variables).
Model 2b: Prediction of habitual physical activity using data from questionnaire variables (penalized regression)
Time frame: Accelerometer data is collected 1-15 months post collection of questionnaire data.
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 14 Jun 2022.
- Derived from this study: PubMed 34548350Fonvig CE, Troelsen J, Dunkhase-Heinl U, Lauritsen JM, Holsgaard-Larsen A. Predictors of physical activity levels in children and adolescents with cerebral palsy: clinical cohort study protocol. BMJ Open. 2021 Sep 21;11(9):e047522. doi: 10.1136/bmjopen-2020-047522.
- Individual participant dataSharing planned: No. Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on sex, birth date, and cerebral palsy classification among other. Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.
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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.
Anders Holsgaard-Larsen, Assoc. Prof study director
Department of Clinical Research, University of Southern Denmark.
Christina E Fonvig, MSc principal investigator
Department of Clinical Research, University of Southern Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University of Southern Denmark at 1 site in Denmark.
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 1 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 14 Jun 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 Denmark. 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?
Model 1a: Prediction of habitual physical activity using data from the CPUP registry (time frame: Response variable is measured between 0 and 39 months post registry data (predictive variables).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614207, which also lists 1 linked publication.
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 14 Jun 2022.