Cerebral Palsy

Listen to the Author Podcast, October 2023 of the Open Access paper: Cerebral palsy pain instruments: Recommended tools for clinical research studies by NINDS Cerebral Palsy CDE Project

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Cerebral Palsy Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Cerebral Palsy study start-up

Cerebral Palsy Highlight Summary: Overview of all Cerebral Palsy-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

Form Search Instructions - Please Read Before Searching

The Form Search is designed to filter the CRF Modules, Guidance Documents, and NOCs on this page by Search Term, Domain, Subdomain, and/or Copyright Status. The Copyright field is designed to filter between forms that are freely available online and forms that are copyrighted or trademarked. Please note that regardless of copyright/trademark status, these instruments are not available on this website. All recommended instruments, regardless of copyright status, have informational documents posted on the NINDS CDE website which provide details concerning availability.

Helpful Hints:

Once you have completed your search, the search results will need to be expanded by clicking the Expand All button to view results.

The default setting for Domain, Subdomain and Copyright fields is ‘Any’.

Leave the Search Term(s) field blank to return all results or enter search terms or keywords to return any forms that match the terms that are entered.

For best results, click the Clear button between searches.

Please contact NINDS CDE team (NINDSCDE@emmes.com) in case you encounter any search difficulties.

Click here for additional instructions

Participant Characteristics
Demographics
CRF Module/Guidance CDEs
Demographics CDE Details
General Core CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Assessments and Examinations
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Gait Analysis CDE Details
Vital Signs CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Mutation Analysis CDE Details
Outcomes and End Points
Visual-Spatial Processing
CRF Module/Guidance CDEs
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) N/A
Family and Environment
CRF Module/Guidance CDEs
Child and Adolescent Scale of Environment (CASE) N/A
Family Assessment Device (FAD) N/A

Overview

The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team developed Version 1.0 of the CP CDEs in 2015 through a partnership between NINDS and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM).

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, Guidance documents and Instrument Notice of Copyright (NOC) documents. The CRF Modules logically organize the CDEs for data collection, the Guidance documents provide further information about the CDE, and the NOC documents include perinent information on recommended instruments. The CDE, CRF Modules, Guidance documents and NOCs presented are organized into domains which are intuitive and common in clinical research studies. Version 1.0 of the Cerebral Palsy CDEs were released in 2016.

The Cerebral Palsy CDE Oversight Committee (OC) was created in 2017 to periodically review, direct the updating, and advance the development of the CP CDEs.

Since 2017 the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018 the CP OC developed and posted the External Device – CP CRF, and in 2020 developed and posted the Participant Condition Characteristics CRF on the Cerebral Palsy data standards page.

In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process, the CP OC formed two subgroups. The CP Pain subgroup recommended 15 Pain Instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.

After a public review period of the draft CP CDEs, from April 27, 2022 to June 1, 2022, the CP OC recommended 15 Pain Instruments and six Orthopedic Surgical CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022. In September 2022, the CP Pain and CP Orthopedic Surgery subgroups presented the development of their respective CDEs and recommendations for pain instruments at the 76th Annual AACPDM Meeting in Las Vegas, NV.

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

Oversight Committee

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
    Chair
  • Brian Carlson, PhD (Until 2021)
    Ipsen Biopharmaceuticals, Inc., Basking Ridge, New Jersey
  • Diane Damiano, PT, PhD (Until 2018)
    NIH Clinical Center, Bethesda, Maryland
  • Krister P. Freese, MD
    Shriners Hospital for Children, Portland, Oregon
  • Paul Gross
    Cerebral Palsy Research Network, Woodinville, Washington
  • Deborah Gordon Hirtz, MD (Until 2023)
    University of Vermont College of Medicine, Burlington, Vermont
  • Sandra E. Juul, MD, PhD (Until 2020)
    University of Washington, Seattle, Washington
  • Sarah McIntyre, PhD (Until 2021)
    Cerebral Palsy Alliance, University of Sydney, Sydney NSW, Australia
  • Theresa Moulton, PT, PhD
    Northwestern University, Chicago, Illinois
  • Terence Sanger, MD, PhD (Until 2023)
    University of Southern California, Los Angeles, California
  • Veronica Schiariti, MD, PhD
    University of Victoria, Victoria, British Columbia, Canada
  • Angela Shierk, PhD, OTR
    Texas Woman's University, Denton, Texas
  • M. Wade Shrader, MD
    Nemours/Alfred I. duPont Hospital, Wilmington, Delaware
  • Susan Sienko, PhD
    Shriners Hospital for Children, Portland, Oregon
  • Elaine Stashinko, PhD, RN
    Johns Hopkins University, Baltimore, Maryland
  • Wendy Sullivan
    Cerebral Palsy Foundation, Alpharetta, Georgia
  • Lisa Wagner DHS, OTR/L
    Shriners Hospital for Children, Greenville, South Carolina

AACPDM CDE Steering Committee

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

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

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

Integrated Across Working Groups

Integrated 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

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

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

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
    NINDS CDE Program Director, 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 Company, LLC, Rockville, Maryland
  • Clara Aman, MPH (Until 2023)
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Robin S. Feldman, BS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland

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

The need to develop a common data set of meaningful measurements for Cerebral Palsy (CP) was identified as a priority area of the American Academy of Cerebral Palsy and Developmental Medicine’s (AACPDM) 2013–2017 strategic plan. In 2015, the CP specific Common Data Elements (CDEs) were developed through a partnership between the National Institute of Neurological Disorders and Stroke (NINDS) and the AACPDM. Version 1.0 of the CP CDEs was posted on the CP Data Standards page in 2016.

In 2017, the CP CDE Oversight Committee (OC) was created to periodically review, direct the updating, and advance the development of the CP CDEs. Since 2017, the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018, the CP OC developed and posted the External Devices – CP case report form (CRF) and in 2020 developed the Participant Condition Characteristics CRF.

In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process the CP OC formed two subgroups. The CP Pain subgroup recommended 15 pain instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.

The CP Pain subgroup reviewed a total of 184 assessments: 22 NINDS CDE CRFs across disorders; 23 NINDS CDEs across disorders related to pain; 101 pain measures from the NIH HEAL Initiative; and 38 from a literature review. These assessments were reviewed using the following criteria to recommend the selected 15 pain instruments:

  • Assessment was developed specifically for chronic pain
  • Assessment was developed for pediatric populations (children 0 to 18 years)
  • Main focus of the assessment is pain
    • more than 3 questions
  • Assessment fits within one of the pain categories
    • intensity, interference, behavior, quality, or location
  • Assessment is available in English

The CP Orthopedic Surgery subgroup assessed the Cerebral Palsy Research Network’s (CPRN) Orthopedic Registry Elements to develop CP orthopedic surgery CDEs. The CPRN Orthopedic Registry Elements and Data Forms were chosen as a basis for these CDEs because these elements have been vetted by CPRN’s Orthopedic Registry Task Force of renowned orthopedic surgeons allowing the subgroup to select, organize and augment the registry elements more quickly to develop the NINDS Orthopedic Surgery CDEs.

The CP Pain Instruments and Orthopedic Surgery CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022.

A complete listing of the Pain Instruments and Orthopedic Surgery CRFs and CDE data dictionaries may be found in the CP CDEs Revision History document linked above.