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

Abstract

Study DesignThis is a focused review article.ObjectivesTo 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.MethodsThis 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.ResultsThere 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.ConclusionThere 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.SponsorsCraig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

Development of Walking indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project

“…The 10MWT has been recommended previously for use with individuals with SCI/D by numerous groups of expert clinicians and researchers. 15,17,41 Further, it is a walking measure that has been reported to change in response to inpatient SCI rehabilitation. 42 The disadvantage of the 10MWT, however, is that it is appropriate only for those individuals with SCI who can walk without the assistance of another person (i.e.…”

Familiarization with treadmill walking: How much is enough?

“…Walking impairment is associated with significant reductions in functional independence and an increased risk of falls and subsequent injury, morbidity and mortality 4 – 6 . Investigations into new therapies and interventions for locomotor disorders generally use ordinal clinical scores and scales, often with poor sensitivity and reliability, as well as simple time- or distance-based walking assessments to measure therapeutic responses 7 – 9 .…”

Targeted Walking in Incomplete Spinal Cord Injury: Role of Corticospinal Control

“…Clinical walking tests and gait analysis of ordinary walking are used to assess locomotor function and rehabilitation outcomes after iSCI. These assessments are, however, unable to separately investigate spinal and supraspinal aspects contributing to deficits and recovery 6 . Assessments with systematic demands on different aspects of locomotor control promise better characterization and monitoring of deficits and treatment effects.…”