- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137005
Cerebral Palsy Adult Transition Longitudinal Study (CPAT)
Walking and Its Effect on Health and Function in Individuals With Cerebral Palsy as They Transition to Adulthood: A Health Outcomes Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cerebral Palsy
Patients with cerebral palsy who were seen at the Center for Gait and Movement Analysis (CGMA) at Children's Hospital Colorado as children.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from baseline Instrumented Gait Analysis (IGA) at up to 15 years
Time Frame: baseline and up to 15 years
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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.
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baseline and up to 15 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples
Time Frame: one time-point cross-sectional study
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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.
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one time-point cross-sectional study
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Fatigue Measure
Time Frame: one time-point cross-sectional study
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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.
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one time-point cross-sectional study
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NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life
Time Frame: one time-point cross-sectional study
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Questionnaire measures of patients symptoms, functioning, and health-related quality of life.
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one time-point cross-sectional study
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Employment Status
Time Frame: one time-point cross-sectional study
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Demographic data collection using a questionnaire.
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one time-point cross-sectional study
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The World Health Organization Disability Assessment Schedule (WHODAS II)
Time Frame: one time-point cross-sectional study
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Instrument providing a global measure of disability across six domains.
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one time-point cross-sectional study
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Self-Efficacy
Time Frame: one time-point cross-sectional study
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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
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one time-point cross-sectional study
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Life Style Assessments
Time Frame: one time-point cross-sectional study
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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. |
one time-point cross-sectional study
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Cognitive Battery
Time Frame: one time-point cross-sectional study
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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. |
one time-point cross-sectional study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James J Carollo, Ph.D., University of Colorado Denver, Anschutz Medical Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0367
- H133G130200 (Other Grant/Funding Number: National Institute on Disability and Rehabilitation Research (NIDRR))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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