Cerebral PalsyCPATNCT02137005
Cerebral Palsy Adult Transition Longitudinal Study
An observational study of Cerebral Palsy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2014to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this 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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- walking, gait disorders, neurologic, health status, cognition, quality of life, Transition to Adult Care
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Instrumented Gait Analysis (IGA) at 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.
Measured: baseline and up to 15 years
Secondary outcomes (8)
Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples
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.
Measured: one time-point cross-sectional study
Fatigue Measure
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.
Measured: one time-point cross-sectional study
NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life
Questionnaire measures of patients symptoms, functioning, and health-related quality of life.
Measured: one time-point cross-sectional study
Employment Status
Demographic data collection using a questionnaire.
Measured: one time-point cross-sectional study
The World Health Organization Disability Assessment Schedule (WHODAS II)
Instrument providing a global measure of disability across six domains.
Measured: one time-point cross-sectional study
Self-Efficacy
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
Measured: one time-point cross-sectional study
Life Style Assessments
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.
Measured: one time-point cross-sectional study
Cognitive Battery
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.
Measured: one time-point cross-sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study start1 May 2014
- Primary completion30 Sep 2017
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- James J Carollo, Ph.D., Principal investigator, University of Colorado Denver, Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137005
- Sponsor's protocol ID
- 14-0367
- Other IDs
- H133G130200
- Acronym
- CPAT
- Status last verified
- Jun 2026
- First submitted
- 7 May 2014
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking and Its Effect on Health and Function in Individuals With Cerebral Palsy as They Transition to Adulthood: A Health Outcomes Study
- ClinicalTrials.gov ID
- NCT02137005
- Acronym / sponsor ID
- CPAT / 14-0367
- Conditions
- Cerebral Palsy
- Keywords
- walking, gait disorders, neurologic, health status, cognition, quality of life, Transition to Adult Care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples
Time frame: one time-point cross-sectional study
Fatigue Measure
Time frame: one time-point cross-sectional study
NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life
Time frame: one time-point cross-sectional study
Employment Status
Time frame: one time-point cross-sectional study
The World Health Organization Disability Assessment Schedule (WHODAS II)
Time frame: one time-point cross-sectional study
Self-Efficacy
Time frame: one time-point cross-sectional study
Life Style Assessments
Time frame: one time-point cross-sectional study
Cognitive Battery
Time frame: one time-point cross-sectional study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Carollo, Ph.D. principal investigator
University of Colorado Denver, Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Instrumented Gait Analysis (IGA) at up to 15 years (time frame: baseline and up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.