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Domains of outcomes in spinal cord injury for clinical trials to improve neurological function

Ralph J. Marino, MD, MSCE

Figure 1. World Health Organization (WHO) International Classification of Functioning, Disability, and Health model of functioning.

In clinical trials for improving spinal cord function, one must show that the treatment not only directly affects neurological function but also results in meaningful improvement for the patient. However, function can be improved with equipment or new techniques without any change in spinal cord function. This article reviews domains or types of outcome measures relevant to clinical trials in spinal cord injury. The World Health Organization's model of functioning was modified to include impairment (strength and sensation), capability/functional limitation (actions such as grasping and reaching), and activity (capacity, ability to perform an activity in a standard environment; and performance, ability to perform an activity in one's usual environment). An understanding of different types of functional outcomes will improve selection of appropriate instruments for determining clinical trials outcomes.

Volume 44 Number 1 2007
Pages 113 — 122

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