Cerebral Palsy Adult Transition Longitudinal Study

NCT02137005 | Active Not Recruiting DMC

• 2 other identifiers: 14-0367H133G130200
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

walking; gait disorders, neurologic; health status; cognition; quality of life; Transition to Adult Care

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and up to 15 years

Secondary Outcomes (8)

• Metabolic, Inflammatory, and Neurotrophic Markers Blood Samples

  one time-point cross-sectional study

• Fatigue Measure

  one time-point cross-sectional study

• NIH Patient Reported Outcomes Measurement System (PROMIS) and Health-Related Quality of Life

  one time-point cross-sectional study

• Employment Status

  one time-point cross-sectional study

• The World Health Organization Disability Assessment Schedule (WHODAS II)

  one time-point cross-sectional study

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James J Carollo, Ph.D.

  University of Colorado Denver, Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: September 30, 2017
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)