Cerebral Palsy

Data Standards

The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team have released Version 1.0 of the CP CDEs. The NINDS, other Federal agencies, and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. The first set of CDEs for Cerebral Palsy was developed in 2015–2016. The Core and Supplemental-Highly Recommended CDEs to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analyses across studies. Consistency of the data elements and the CDE formats are kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing and help educate new clinical investigators.

Organized by working groups (Engagement and Quality of Life Assessments/Data; Health, Growth, Genetics, Comorbidities and Labs; Neurocognitive, Social, and Emotional Assessments; Neuroimaging Diagnostics; Neuromotor Skills and Functional Assessments; and Participant Characteristics and Disease/Injury Related Events), often used in clinical studies, data standards include:

An overview of all Cerebral Palsy CDE recommendations can be found in the Cerebral Palsy CDE Highlight Summary document. For your reference, a zip file containing all the current Cerebral Palsy CDE template CRF modules can be downloaded below.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and sub-domain.

NIH Resources
NIH Resources
CRF Module/Guideline CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guideline CDEs
Engagement and Quality of Life Assessments and Data Working Group Summary N/A
Health Growth Genetics Comorbidities and Labs Working Group Summary N/A
Neurocognitive Social Emotional Assessments Working Group Summary N/A
Neuroimaging Diagnostics Working Group Summary N/A
Neuromotor Skill Functional Assessments Working Group Summary N/A
Participant Characteristics and Disease and Injury Related Events Working Group Summary N/A
Participant Characteristics
Demographics
CRF Module/Guideline CDEs
Demographics CDE Details
General Core CDE Details
Social Status
CRF Module/Guideline CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guideline CDEs
Behavioral History CDE Details
Family History CDE Details
Medical History CDE Details
Motor Development History CDE Details
Surgical and Hospitalization History CDE Details
Vaccination History CDE Details
Epidemiology/Environmental History
CRF Module/Guideline CDEs
Risk Factor Questionnaire (RFQ) - Physical Activity and Sleep CDE Details
Risk Factor Questionnaire (RFQ) - Residential History CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guideline CDEs
Bimanual Fine Motor Function (BFMF) N/A
Communication Function Classification System (CFCS) N/A
Eating and Drinking Classification System (EDACS) N/A
Gross Motor Function Classification System - Expanded & Revised (GMFCS - ER) N/A
Manual Ability Classification System (MACS) N/A
Participant Condition Characteristics CDE Details
Assessments and Examinations
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guideline CDEs
Mutation Analysis CDE Details
Imaging Diagnostics
CRF Module/Guideline CDEs
Neuroimaging Cerebral Palsy Magnetic Resonance Imaging CDE Details
Physical/Neurological Examination
CRF Module/Guideline CDEs
Neurological Examination CDE Details
Physical Examination CDE Details
Vital Signs and Other Body Measures
CRF Module/Guideline CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Therapies
CRF Module/Guideline CDEs
External Devices - CP CDE Details
Occupational Therapy Treatment Session: Cerebral Palsy CDE Details
Physical Therapy Individual Session CDE Details
Rehabilitation Therapies - Episodes of care CDE Details
Speech and Language Therapy Treatment Session CDE Details
Outcomes and End Points
Functional Outcomes
CRF Module/Guideline CDEs
10 Meter Timed Walk N/A
6 Minute Walk Test N/A
Functional Independence Measure N/A
Functional Independence Measure for Children (WeeFIM) N/A
Functional Mobility Scale N/A
Gait Deviation Index N/A
Goal Attainment Scale (GAS) N/A
Instrumented Gait Analysis N/A
Observational Gait Scale N/A
Pediatric Evaluation of Disability Inventory (PEDI) N/A
Pediatric Orthopedic Society of North America Measure (PODCI) N/A
Stride Analysis and Gait Variability N/A
Timed Up and Go (TUG) N/A
Walking Speed CDE Details
Motor Function
CRF Module/Guideline CDEs
ABILHAND-Kids N/A
Alberta Infant Motor Scale N/A
Assisting Hand Assessment (AHA) N/A
Box and Blocks Test of Manual Dexterity N/A
Canadian Occupational Performance Measure (COPM) N/A
Gross Motor Function Measure (GMFM-88, GMFM-66) N/A
Jebsen-Taylor Hand Function Test N/A
Manual Muscle Testing-Using the Medical Research Council Muscle Grading Scale CDE Details
Maximum Voluntary Isometric Contraction Testing (MVICT) N/A
Melbourne Assessment 2 (MA2) N/A
Nine Hole Peg Test N/A
Prechtl's Assessment of General Movements N/A
Purdue Pegboard N/A
Quality of Upper Extremity Skills Test (QUEST) N/A
Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) N/A
Test of Infant Motor Performance (TIMP) N/A
Participation
CRF Module/Guideline CDEs
Activities Scale for Kids (ASK) N/A
Assessment of Life Habits (Life-H) N/A
Assessment of Preschool Children?s Participation (APCP) N/A
Child and Adolescent Scale of Participation (CASP) CDE Details
Child Engagement in Daily Life N/A
Children?s Assessment of Participation and Enjoyment Scale (CAPE) / Preferences for Activities of Children (PAC) N/A
Evaluation of Social Interaction (ESI) N/A
Lifestyle Assessment Questionnaire for CP (LAQ-CP of LAQ-G) N/A
Participation and Environment Measure for Children and Youth (PEM-CY) N/A
Participation Assessment with Recombined Tools-Objective (PART-O)-17 CDE Details
School Function Assessment (SFA) N/A
Young Children's Participation and Environment Measure (YC-PEM) N/A
Cognitive and Emotional Status
CRF Module/Guideline CDEs
Ages & Stages Questionnaires, Third Edition (ASQ-3) N/A
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Leiter International Performance Scale-3 (Leiter-3) N/A
NIH Toolbox Cognitive Battery CDE Details
Pediatric Sleep Questionnaire (PSQ) N/A
PROMIS Item Bank v1.0 - Sleep Disturbance CDE Details
Sleep Disorders Inventory for Students N/A
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) CDE Details
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) CDE Details
Wechsler Intelligence Scale for Children-V (WISC-V) N/A
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) N/A
Quality of Life/Patient Reported Outcomes
CRF Module/Guideline CDEs
Assessment of Quality of Life (AQoL) N/A
Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) N/A
Cerebral Palsy Quality of Life (CP QOL) N/A
Child Health and Illness Profile (CHIP-CE) N/A
Child Health Assessment Questionnaire (CHAQ) N/A
Child Health Questionnaire (CHQ) N/A
EuroQoL-5 Dimension Questionnaire-Youth (EQ-5DY) N/A
Generic Children?s Quality of Life Measure (GCQ) N/A
Health Related Quality of Life-14 (HRQOL-14) N/A
Health Utilities Index (HUI) N/A
KIDSCREEN-52 N/A
Multidimensional Students Life Satisfaction Scale (MSLSS) N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Pediatric Quality of Life Inventory (PEDSQL) CDE Details
Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL-CP) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Short Form 36-Item Health Survey (SF-36) CDE Details
The DISABKIDS Chronic Generic Module (DCGM-37) N/A
World Health Organization Quality of Life Assessment (WHOQOL-BREF) CDE Details
Spasticity/Movement
CRF Module/Guideline CDEs
Barry Albright Dystonia Scale (BADS) N/A
Dyskinesia Impairment Scale (DIS) N/A
Hypertonia Assessment Tool (HAT) N/A
Modified Ashworth Scale ? Limb Tone Testing CDE Details
Selective Control Assessment of the Lower Extremity (SCALE) N/A
Tardieu Scale CDE Details
Visual-Spatial Processing
CRF Module/Guideline CDEs
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) CDE Details
Executive Functioning
CRF Module/Guideline CDEs
Behavior Rating Inventory of Executive Function (BRIEF) ? Second Edition (BRIEF-2) CDE Details
Behavior Rating Inventory of Executive Function- Preschool Version (BRIEF-P) N/A
Behavioral Rating Inventory of Executive Function ? Adult Version (BRIEF-A) CDE Details
Conners Continuous Performance Test 3rd Edition (Conners CPT 3) CDE Details
Conners Kiddie Continuous Performance Test 2 (K-CPT 2) N/A
Corsi Block Wechsler Nonverbal Scale of Ability (WNV) N/A
Delis-Kaplan Executive Function System (D-KEFS) N/A
Kaufman Assessment Battery for Children N/A
Mullen Scales of Early Learning (MSEL) N/A
Test of Everyday Attention for Children (TEA-Ch) CDE Details
Test of Variables of Attention (TOVA) N/A
Symbol Digit Modalities Test CDE Details
Trunk Control/Balance
CRF Module/Guideline CDEs
Berg Balance Scale (BBS) CDE Details
Early Assessment of Balance (EAB) N/A
Functional Reach Test (FRT) N/A
Level of Sitting Scale (LSS) N/A
Segmental Assessment of Trunk Control (SATCo) N/A
Trunk Control Measurement Scale (TCMS) N/A
Social Emotional
CRF Module/Guideline CDEs
Brief Infant Toddler Social Emotional Assessment (BITSEA) N/A
Social Communication Questionnaire (SCQ) N/A
Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2) CDE Details
Wisconsin Card Sorting Test (WCST) N/A
Memory
CRF Module/Guideline CDEs
Brief Visuospatial Memory Test Revised (BVMT-R) CDE Details
California Verbal Learning Test - Children (CVLT-C) CDE Details
California Verbal Learning Test - Second Edition (CVLT-II) CDE Details
Rey Auditory Verbal Learning Test (RAVLT) CDE Details
Wechsler Memory Scale IV (WMS-IV) CDE Details
Family and Environment
CRF Module/Guideline CDEs
Child and Adolescent Scale of Environment (CASE) CDE Details
Family Assessment Device (FAD) CDE Details
Speech Language and Communication
CRF Module/Guideline CDEs
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5) N/A
Clinical Evaluation of Language Fundamentals-Preschool-2 (CELF-Preschool-2) N/A
Comprehensive Test of Phonological Processing (CTOPP) N/A
Dynamic Evaluation of Motor Speech Skills (DEMSS) N/A
Edinburgh Cognitive Behavioral ALS Screen (ECAS) N/A
Goldman Fristoe Test of Articulation 2 (GFTA-2) N/A
Language Sample Analysis N/A
Peabody Picture Vocabulary Test 4th Edition (PPVT?-4) N/A
Percentage of Consonants Correct-Revised (PCC-R) N/A
Preschool Language Scales ? Fifth Edition (PLS-5) N/A
Pure Tone Threshold Audiometry N/A
Speech Language Profile Groups (SLPG) N/A
Test of Children?s Speech (TOCS) N/A
Verbal Motor Production Assessment for Children (VMPAC) N/A
Viking Speech Scale (VSS) N/A

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at http://www.cssrs.columbia.edu).

Accessibility Statement

The NINDS CDE Team has requested, and in many cases received, permission to post proprietary instruments/scales recommended by the CDE Working Groups to this site. When permission is granted, the documents are posted in the exact format they were received in order to maintain the validity of the instrument. If approval is not granted for the instrument to be reproduced on this site, with the author/copyright holder’s permission, a link is posted to an external Web site where users can get more information about the instrument. If you have difficulty accessing either the proprietary instruments/scales or the external links, please contact the NINDS Office of Clinical Research at carolina.mendoza-puccini@nih.gov.

Overview

To develop the Cerebral Palsy CDEs, the Cerebral Palsy CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Engagement and Quality of Life Assessments/Data
  • Health, Growth, Genetics, Comorbidities and Labs
  • Neurocognitive, Social, and Emotional Assessments
  • Neuroimaging Diagnostics
  • Neuromotor Skills and Functional Assessments
  • Participant Characteristics and Disease/Injury Related Events

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.

Roster

The Cerebral Palsy (CP) CDE Working Group was comprised of seven different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The CP CDE Working Group was supported by the NINDS CDE Team. The complete CP CDE Working Group roster and the rosters by Subgroup are shown below:

Complete Cerebral Palsy CDE Roster

Oversight Committee

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
  • Brian Carlson, PhD
    Ipsen Biopharmaceuticals, Inc., Basking Ridge, New Jersey
  • Diane Damiano, PT, PhD (Until 2018)
    NIH Clinical Center, Bethesda, Maryland
  • Paul Gross
    Cerebral Palsy Research Network, Woodinville, Washington
  • Deborah Gordon Hirtz, MD
    University of Vermont College of Medicine, Burlington, Vermont
  • Sandra E. Juul, MD, PhD
    University of Washington, Seattle, Washington
  • Sarah McIntyre, PhD
    Cerebral Palsy Alliance, University of Sydney, Sydney NSW, Australia
  • Theresa Moulton, PT, PhD
    Northwestern University, Chicago, Illinois
  • Terence Sanger, MD, PhD
    University of Southern California, Los Angeles, California
  • Veronica Schiariti, MD, PhD
    University of British Columbia, Vancouver, British Columbia, Canada
  • Susan Sienko, PhD
    Shriners Hospital for Children, Portland, Oregon
  • Wendy Sullivan
    Reaching for the Stars. A Cerebral Palsy Foundation, Alpharetta, Georgia

AACPDM CDE Steering Committee

  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
    Co-Chair
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Laura Prosser, PT, PhD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Sharon Ramey, PT, PhD
    Virginia Polytechnic Institute, Roanoke, Virginia
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama

Engagement and Quality of Life Assessments/Data

  • Susan Sienko, PhD
    Shriners Hospitals for Children, Portland, Oregon
    Chair
  • Kristie Bjornson, PT, PhD
    Seattle Children's, Seattle, Washington
  • Stephanie DeLuca, PhD
    Virginia Polytechnic Institute, Blacksburg, Virginia
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Margaret Wallen, OT, PhD
    University of Sydney, Sydney, Australia

Health, Growth, Genetics, Co-Morbidities and Labs

  • Theresa Moulton, DPT, PhD
    Northwestern University, Chicago, Illinois
    Chair
  • Kathleen M. Kolaski, MD
    Wake Forest Baptist Health, Winston-Salem, North Carolina
  • Sebastian Schroeder, MD
    Ludwig-Maximilians-University of Munich, Munich, Bavaria, Germany
  • Benjamin J. Shore, MD
    Harvard Medical School, Boston, Massachusetts
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
  • Gordon Worley, MD
    Duke University School of Medicine, Durham, North Carolina

Intregrated Across Working Groups

  • Veronica Schiariti, MD, PhD
    Children's & Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada
    Chair
  • Sylvia Ounpuu, MSc
    University of Connecticut, Farmington, Connecticut
  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
  • Mary Gannotti, PT, PhD
    University of Hartford, Hartford, Connecticut
  • Bernadette Gillick, PT, PhD
    University of Minnesota, Minneapolis, Minnesota

Neurocognitive, Social, and Emotional Assessments/Data

  • Sharon Ramey, PT, PhD
    PhD, Virginia Polytechnic Institute, Roanoke, Virginia
    Chair
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Michael Msall, MD
    University of Chicago, Chicago, Illinois
  • Seth A. Warschausky, PhD
    University of Michigan, Ann Arbor, Michigan
  • Kathi Zebracki, PhD
    Loyola University Chicago, Chicago, Illinois

Neuroimaging Diagnostics Neuroimaging Diagnostics

  • Eric Levey, MD
    Kennedy Krieger Institute, Baltimore, Maryland
    Chair
  • Patrick Barnes, MD
    Stanford University, Palo Alto, California
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Hannah Glass, MD
    University of California San Francisco, San Francisco, California
  • Andrea Poretti, MD
    Johns Hopkins University, Baltimore, Maryland
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California

Neuromotor Skill and Functional Assessments

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
    Chair
  • Michael Aiona, MD
    Shriners Hospitals for Children, Portland, Oregon
  • Mary Jo Cooley Hidecker, PhD MS MA CCC-A/SLP
    University of Wyoming, Laramie, Wyoming
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Christopher Joseph, MS PT
    Kennedy Krieger Institute, Baltimore, Maryland
  • Claire Morress, OT, PhD
    Cincinnati Children's Perlman Center, Cincinnati, Ohio
  • Laura Prosser, PT, PhD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington

Participant Characteristics and Disease/Injury Related Events

  • Sarah McIntyre, PhD
    University of Sydney, Sydney, Australia
    Chair
  • Katherine Alter, MD
    NIH Clinical Center, Bethesda, Maryland
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Deborah Thorpe, PT, PhD
    University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

NINDS CDE Team

  • James I. Koenig, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH (Until 2016)
    National Institute for Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Robin S. Feldman, BS, MBA
    The Emmes Corporation
  • Katelyn Gay, BS
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Cerebral Palsy CDEs Revision History