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Author Notes:

Marc Bolliger marc.bolliger@balgrist.ch

The authors declare that they have no conflict of interest.

Subjects:

Research Funding:

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

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Clinical Neurology
  • Rehabilitation
  • Neurosciences & Neurology
  • BERG BALANCE SCALE
  • FORCE-FIELD ADAPTATION
  • WALKING INDEX
  • 6-MINUTE WALK
  • MULTIPLE-SCLEROSIS
  • GAIT ANALYSIS
  • AMBULATION
  • POPULATION
  • RESPONSIVENESS
  • VALIDATION

Lower extremity outcome measures: considerations for clinical trials in spinal cord injury

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Journal Title:

Spinal Cord

Volume:

Volume 56, Number 7

Publisher:

, Pages 628-642

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2018 The Author(s).

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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