Abstract

Study Design:

This is a focused review article.

Objectives:

To identify important concepts in lower extremity (LE) assessment with a focus on locomotor outcomes and provide guidance on how existing outcome measurement tools may be best used to assess experimental therapies in spinal cord injury (SCI). The emphasis lies on LE outcomes in individuals with complete and incomplete SCI in Phase II-III trials.

Methods:

This review includes a summary of topics discussed during a workshop focusing on LE function in SCI, conceptual discussion of corresponding outcome measures and additional focused literature review.

Results:

There are a number of sensitive, accurate, and responsive outcome tools measuring both quantitative and qualitative aspects of LE function. However, in trials with individuals with very acute injuries, a baseline assessment of the primary (or secondary) LE outcome measure is often not feasible.

Conclusion:

There is no single outcome measure to assess all individuals with SCI that can be used to monitor changes in LE function regardless of severity and level of injury. Surrogate markers have to be used to assess LE function in individuals with severe SCI. However, it is generally agreed that a direct measurement of the performance for an appropriate functional activity supersedes any surrogate marker. LE assessments have to be refined so they can be used across all time points after SCI, regardless of the level or severity of spinal injury.

Sponsors:

Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

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Funding:

Financial support for a workshop was provided by the Craig H. Neilsen Foundation and the Spinal Cord Outcomes Partnership Endeavour.

Author information

Affiliations

  1. Spinal Cord Injury Center, University Hospital Balgrist, University Zurich, Zurich, Switzerland

    • Marc Bolliger
    • , Lea Awai
    • , Chris S Easthope
    • , Björn Zörner
    •  & Armin Curt
  2. Swiss Center for Clinical Movement Analysis (SCMA), Zurich, Switzerland

    • Marc Bolliger
    •  & Armin Curt
  3. Acorda Therapeutics, Ardsley, NY, USA

    • Andrew R. Blight
  4. Shepherd Center, Georgia Institute of Technology, School of Biological Sciences, Emory University School of Medicine, Division of Physical Therapy, Atlanta, GA, USA

    • Edelle C. Field-Fote
  5. Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada

    • Kristin Musselman
  6. Department of Physical Therapy, University of Toronto, Toronto, ON, Canada

    • Kristin Musselman
  7. Department of Neuroscience, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada

    • Serge Rossignol
  8. School of Rehabilitation, Faculty of Medicine, Université de Montréal, and Centre de recherche interdisciplinaire en réadaptation (CRIR), Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM) du CIUSSS du Centre-Sud-de-l’Ile-de-Montréal, Montreal, QC, Canada

    • Dorothy Barthélemy
  9. Department of Rehabilitation, Faculty of Medicine, Université Laval, Québec, Canada

    • Laurent Bouyer
  10. Rehabilitation Engineering Laboratory, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada

    • Milos R. Popovic
  11. Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada

    • Milos R. Popovic
  12. Department of Neurology, Spinal Cord Injury Division and Departments of Neuroscience and Physical Medicine and Rehabilitation, The Neurological Institute, The Ohio State University, Wexner Medical Center, Columbus, OH, USA

    • Jan M. Schwab
  13. Department of Physical Medicine and Rehabilitation, University of Pittsburgh & Department of Veterans Affairs, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA

    • Michael L Boninger
  14. Methodist Rehabilitation Center, University of Mississippi Medical Center and Jackson VA Medical Center, Jackson, MS, USA

    • Keith E. Tansey
  15. Spinal Cord Unit and Spinal Rehabilitation (SpiRe) laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

    • Giorgio Scivoletto
  16. Craig H. Neilsen Foundation, Encino, CA, USA

    • Naomi Kleitman
    •  & Linda A. T. Jones
  17. School of Rehabilitation, Université de Montréal and Pathokinesiology Laboratory, Centre for Interdisciplinary Research in Rehabilitation, Institut universitaire sur la réadaptation en déficience physique de Montréal, CIUSSS Centre-Sud-de-l’Île-de-Montréal, Montreal, QC, Canada

    • Dany H. Gagnon
    •  & Sylvie Nadeau
  18. University of British Columbia, Vancouver, BC, Canada

    • Dirk Haupt
    •  & John Steeves
  19. Spinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany

    • Ruediger Rupp
  20. Craig Hospital, Englewood, Colorado, University of Colorado School of Medicine, Colorado, USA

    • Dan Lammertse

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Conflict of interest

The authors declare that they have no conflict of interest.

Corresponding author

Correspondence to Marc Bolliger.

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