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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
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
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.

Condition or disease
Cerebral Palsy

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 Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Employment Status [ Time Frame: one time-point cross-sectional study ]
    Demographic data collection using a questionnaire.

  5. 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.

  6. 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

  7. 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.


  8. 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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: James J Carollo, Ph.D. 720-777-5806 james.carollo@childrenscolorado.org
Contact: Patricia C Heyn, Ph.D. 720-777-0930 Patricia.Heyn@ucdenver.edu

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: James J Carollo, Ph.D., PE    720-777-5806    james.carollo@ucdenver.edu   
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         
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
Investigators
Principal Investigator: James J Carollo, Ph.D. University of Colorado Denver, Anschutz Medical Campus

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02137005     History of Changes
Other Study ID Numbers: 14-0367
H133G130200 ( Other Grant/Funding Number: National Institute on Disability and Rehabilitation Research (NIDRR) )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by University of Colorado, Denver:
walking
gait disorders, neurologic
health status
cognition
quality of life
Transition to Adult Care

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases