An observational study in Cerebral Palsy, sponsored by Tatiana Besse-Hammer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Tatiana Besse-Hammer · Observational
Cerebral palsy (CP) results from damage to the developing brain of the fetus or infant. These non-progressive lesions cause a set of permanent movement and posture disorders, responsible for activity limitations. These disorders are often accompanied by sensory, perceptual, cognitive impairments, communication and behavioral disorders, and sometimes epilepsy and/or secondary musculoskeletal problems. It is the leading cause of motor disability in childhood and affects 200 newborns per year in Belgium.
Cerebral palsy affects two to three people in every 1,000 of the world's population. The prevalence, incidence and most common causes have varied over time due to significant changes in obstetric care and pediatric care. In 75% of all cases of cerebral palsy, the lesions occurred before childbirth.
The population of adults diagnosed with cerebral palsy is increasing as the survival rate of children born with a disability increases. This population requires adapted and expert care services for the continuous monitoring and management of their condition. In addition, the development of additional health problems in adulthood increases the need for permanent access to care structures. Adults with CP have a higher rate of chronic health problems (ischemic heart disease) and a deterioration in their functional status. They would also have difficulty having a social and professional life which negatively impacts their quality of life.
A large number of adults with CP cannot access appropriate care or medico-social structures. This results in a significant involvement of caregivers (family environment or close entourage).
The role of caregiver is at the origin of a significant physical and psychological burden, whether for underage patients or adult patients. The study of this burden is well known in certain neurological pathologies (head trauma, multiple sclerosis, brain tumors). In the field of cerebral palsy, a study showed that the primary caregivers of children with CP had higher levels of psychological and physical disorders than the control group studied (caregivers of healthy children).
Currently, there are very few studies assessing the burden of caregivers of adults with cerebral palsy. The objective of this study is to analyze, through various specific questionnaires, the quality of life and the presence of depressive symptoms linked to the burden of caregivers of adults and children with cerebral palsy, taking into account socio-economic and environmental data.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 50 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Tatiana Besse-Hammer is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Caregivers (family environment or close entourage) for adults and children with cerebral palsy.
Other: Questionnaire
Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.
Hospital Anxiety and depression scale (HAD)
The HAD scale is an instrument used to screen for anxiety and depressive disorders. An overall score is calculated by adding the responses to the 14 items (varies from 0 to 42) as well as two sub-scores corresponding to the two subscales (ranging from 0 to 21). The higher the scores, the more severe the symptomatology.
Time frame: 15 minutes
ISPN (Nottingham Health Profile - NHP)
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Time frame: 15 minutes
Zarit scale
The Zarit scale assesses the burden felt by caregivers. The total score, which is the sum of the scores obtained for each of 22 items, varies from 0 to 88. A lower score or equal to 20 indicates little or no charge; a score between 21 and 40 indicates a light load; a score between 41 and 60 indicate a moderate load; a score above 60 indicates a severe load.
Time frame: 15 minutes
SF12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A high score corresponds to a better state of health.
Time frame: 15 minutes
Plan to share: No
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Ran from Nov 2019 to primary completion in Oct 2022, 34 months.
Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's 34 months is above that.
Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Tatiana Besse-Hammer