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

Spinal Cord, 2018 · DOI: 10.1038/s41393-018-0097-8 · Published: April 27, 2018

Spinal Cord Injury Research Methodology & Design

Simple Explanation

This review discusses lower extremity (LE) assessments for spinal cord injury (SCI) clinical trials, focusing on locomotor outcomes. It emphasizes using existing measurement tools to assess experimental therapies in individuals with both complete and incomplete SCI in Phase II-III trials. The review summarizes topics discussed during a workshop on LE function in SCI, including conceptual discussions of outcome measures and literature review. It highlights the availability of sensitive and accurate tools for measuring quantitative and qualitative aspects of LE function. The review concludes that no single outcome measure can assess all individuals with SCI across varying injury severity and levels. It suggests using surrogate markers for severe SCI cases, emphasizing the importance of direct performance measurements for appropriate functional activities.

Study Duration

Not specified

Participants

Individuals with complete and incomplete SCI

Evidence Level

Review Article

Key Findings

1
There are sensitive, accurate, and responsive outcome tools available for measuring quantitative and qualitative aspects of LE function in SCI patients.
2
In trials involving individuals with very acute injuries, baseline assessments of primary LE outcome measures are often not feasible.
3
No single outcome measure can universally assess all individuals with SCI to monitor changes in LE function, necessitating surrogate markers for severe cases and direct performance measurements for functional activities.

Research Summary

This review identifies 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). 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. 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.

Practical Implications

Outcome Measure Selection

Researchers and clinicians should carefully select LE outcome measures based on the specific goals, patient population, and phase of clinical trials in SCI.

Acute Injury Assessment

Develop and utilize surrogate markers to assess LE function in individuals with severe SCI or acute injuries where direct measurements are not feasible.

Comprehensive Assessment

Employ a combination of clinical LE outcome tools, including biomechanical analyses, to gain more precise information about the efficiency and quality of LE movement patterns.

Study Limitations

1
Lack of a universal outcome measure applicable to all SCI individuals across all severity levels.
2
Many outcome measurement tools do not account for how a functional improvement was achieved (recovery vs. compensation).
3
Feasibility challenges in measuring complex LE functional activities at the acute stage after SCI.

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