Cerebral Palsy Adult Transition Longitudinal Study

• Conditions: Cerebral Palsy

• Registration Number: NCT02137005
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Primary Completion: 2017-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Instrumented Gait Analysis (IGA) at up to 15 years	baseline and up to 15 years	Kinematics - joint angles and positions during over-ground walking. Kinetics - forces measured from force plates during over-ground walking. Gait Deviation Index - overall gait performance score measured from kinematics. Electromyography - measure of muscle activity during over-ground walking. Physical Exam - measure of joint range of motion and muscle strength.

Secondary Outcome Measures

Name	Time	Method
Fatigue Measure	one time-point cross-sectional study	Muscle fatigue will be measured by the Moreau Fatigue Index. This test is performed by doing repeated maximum voluntary concentric knee flexion and extensions at 60 degrees/sec for 35 repetitions.
Self-Efficacy	one time-point cross-sectional study	General Self-Efficacy Scale-12 (GSES-12) assess a general sense of perceived self-efficacy with th eaim to evaluate coping with daily hassles as well as adaptation after experiencing stressful life events
Life Style Assessments	one time-point cross-sectional study	Self-Rated Abilities for Health Practices Scale (SRAHP) - 28-item 5-point scale to measure self-perceived ability to implement health-promoting behaviors.; Comprehensive Health Assessment Motivation Program (CHAMP)/Health \& Wellness Passport - checklist of daily lifestyle and fitness choices that contribute to individuals personal success.
NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life	one time-point cross-sectional study	Questionnaire measures of patients symptoms, functioning, and health-related quality of life.
Employment Status	one time-point cross-sectional study	Demographic data collection using a questionnaire.
Cognitive Battery	one time-point cross-sectional study	Subtests of Wechsler Adult Intelligence Score IV/Wechsler Memory Scale IV (WAIS IV/WMS IV) - standardized psychological evaluation.; Verbal Fluency - subject generates as many words belonging to one semantic category.; NIH Toolbox Cognitive Battery - computerized adaptive test principles to measure cognitive function.
Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples	one time-point cross-sectional study	Blood will be drawn during 1 study visit after fasting for 12 hours. Several different blood analyses will be run on the sample. Blood will not be banked.
The World Health Organization Disability Assessment Schedule (WHODAS II)	one time-point cross-sectional study	Instrument providing a global measure of disability across six domains.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States