Clinical trial NCT02137005: Cerebral Palsy Adult Transition Longitudinal Study
Official title: Walking and Its Effect on Health and Function in Individuals With Cerebral Palsy as They Transition to Adulthood: A Health Outcomes Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Keywords: walking
gait disorders, neurologic
health status
cognition
quality of life
Transition to Adult Care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2014-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort will be selected from a larger cohort of 400 patients that received full, instrumented gait analyses as children at the Center for Gait and Movement Analysis at Children's Hospital Colorado and who are now older than 18.

Brief summary: The purpose of this study is to investigate longitudinally, the walking ability of individuals with cerebral palsy who are transitioning into adulthood and to cross-sectionally examine the health status of these individuals in the context of their walking ability. Young adults who received instrumented gait analysis (IGA) as children will show significant decreases in overall gait performance, as measured by kinematics, kinetics, temporal-spatial parameters, and gait deviation index, compared to their last childhood IGA.

Detailed description: The investigators are proposing a prospective, longitudinal, cross-sectional, and patient-centered outcome study of walking ability and current health status to investigate important health outcomes that impact the quality of life, participation, and activity on adults with cerebral palsy who took part in a gait analysis during childhood at the Center for Gait and Movement Analysis (CGMA). The goal is to see whether their health and walking ability has changed since leaving the Children's Hospital Colorado (CHCO) system and understand if there is a relationship between maintaining proper walking ability and health status. The investigators are including the measure of health outcomes to better understand if a decline in walking ability relates to a decline in health status. The first aim is to study the walking ability of adults with cerebral palsy by comparing their results of a gait analysis to the same results collected when they were children. The second aim is to study the presence of heart disease risk factors by testing each participant's blood levels of lipids, glucose, and insulin. The investigators will also measure each participant's blood pressure. The third aim is to study the relationship(s) between inflammatory markers, neurotrophic factors, and pain and fatigue levels. The investigators will measure inflammatory markers through a blood test and pain and fatigue levels through standardized assessments. The fourth aim is to study each participant's mental health. The investigators will measure this through standardized psychological assessments. The fifth aim is to study each participant's self-perceived health and quality of life as well as employment status. The investigators will measure these levels also through standardized assessments.

Eligibility criteria: Inclusion Criteria:

* Male and female adults (aged 18 years or older) with cerebral palsy (CP)
* Adults with CP who are part of the CGMA data registry
* Adults with CP who have previously participated in an IGA at the CGMA
* Adults with CP who are able to walk (with or without assistance) three times down a \~35 foot walkway at a comfortable and self-selected pace
* Adults with CP who are able to give informed consent, or have a legally authorized representative to give informed consent
* Adults with CP who are able to understand and communicate in English or Spanish (medical interpreters will be utilized for this study when needed)
* If medicated, adults with CP will need to be on a stable medication regimen for at least six months prior to study enrollment (including non-steroidal anti-inflammatory drugs (NSAIDs))
* Adults with CP who are able to devote sufficient time to participate in a health/physical exam, respond to questions asked during assessments, and participate in an IGA
* Adults with CP who have no recent history of seizure or blackout

Exclusion Criteria:

* Male and female children (aged 17 years or younger) with CP
* Adults with CP who have never participated in an IGA at the CGMA
* Adults with CP whose mobility is impaired to the point of being unable to move (even with assistance)
* Adults with CP who are taking any medication(s) that might interfere with the ability to move
* Adults with CP who are unable to devote sufficient time to participate in a health/physical exam, respond to questions asked during assessments, and participate in an IGA
* Adults with CP who have any medical issue impacting performance

Primary outcomes:
measure: Change from baseline Instrumented Gait Analysis (IGA) at up to 15 years
timeFrame: baseline and up to 15 years
Secondary outcomes:
measure: Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples
timeFrame: one time-point cross-sectional study
measure: Fatigue Measure
timeFrame: one time-point cross-sectional study
measure: NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life
timeFrame: one time-point cross-sectional study
measure: Employment Status
timeFrame: one time-point cross-sectional study
measure: The World Health Organization Disability Assessment Schedule (WHODAS II)
timeFrame: one time-point cross-sectional study
measure: Self-Efficacy
timeFrame: one time-point cross-sectional study
measure: Life Style Assessments
timeFrame: one time-point cross-sectional study
measure: Cognitive Battery
timeFrame: one time-point cross-sectional study
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver, Anschutz Medical Campus
name: James J Carollo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: