Lower extremity outcome measures: considerations for clinical trials in spinal cord injury
|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.
|Marc Bolliger, Andrew R. Blight, Edelle C. Field-Fote, Kristin Musselman, Serge Rossignol,Dorothy Barthélemy, Laurent Bouyer, Milos R. Popovic, Jan M. Schwab, Michael L Boninger, Keith E. Tansey, Giorgio, Scivoletto, Naomi Kleitman, Linda A. T. Jones, Dany H. Gagnon, Sylvie Nadeau, Dirk Haupt, Lea Awai, Chris S Easthope, Björn Zörner, Ruediger Rupp, Dan Lammertse, Armin Curt, John Steeves
|Titre de revue/journal, volume et numéro
|Spinal Cord, volume 56.
|Langue de la publication et/ou de traduction
|Anglais (langue d’origine)
|Année de parution
|Université de Zurich, Université de Montréal, Université de la Colombie-britannique
|Lien vers la publication
|Type d’accès à la publication