Cerebral Palsy Adult Transition Longitudinal Study (CPAT)
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|ClinicalTrials.gov Identifier: NCT02137005|
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : January 17, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|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 Start Date :||May 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2018|
Patients with cerebral palsy who were seen at the Center for Gait and Movement Analysis (CGMA) at Children's Hospital Colorado as children.
- Change from baseline Instrumented Gait Analysis (IGA) at up to 15 years [ Time Frame: 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.
- Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples [ Time Frame: 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.
- Fatigue Measure [ Time Frame: 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.
- NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life [ Time Frame: one time-point cross-sectional study ]Questionnaire measures of patients symptoms, functioning, and health-related quality of life.
- Employment Status [ Time Frame: one time-point cross-sectional study ]Demographic data collection using a questionnaire.
- The World Health Organization Disability Assessment Schedule (WHODAS II) [ Time Frame: one time-point cross-sectional study ]Instrument providing a global measure of disability across six domains.
- Self-Efficacy [ Time Frame: 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 [ Time Frame: 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.
- Cognitive Battery [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137005
|Contact: James J Carollo, Ph.D.||firstname.lastname@example.org|
|Contact: Patricia C Heyn, Ph.D.||720-777-0930||Patricia.Heyn@ucdenver.edu|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: James J Carollo, Ph.D., PE 720-777-5806 email@example.com|
|Principal Investigator: James J Carollo, Ph.D., PE|
|Sub-Investigator: Patricia C Heyn, Ph.D.|
|Sub-Investigator: Heather R Ene, MD|
|Sub-Investigator: Pamela E Wilson, MD|
|Sub-Investigator: Amy W Bodkin, PT PhD PCS|
|Sub-Investigator: Zhaoxing Pan, Ph.D., M.B.|
|Sub-Investigator: Timothy D Boyd, Ph.D., MSB|
|Sub-Investigator: Tatiana Oliveira, MD|
|Principal Investigator:||James J Carollo, Ph.D.||University of Colorado Denver, Anschutz Medical Campus|