title: Neurological and functional capacity outcome measures: essential to spinal cord injury clinical trials.
abstract: We intend to demonstrate that future treatment strategies in spinal cord injury (SCI) rehabilitation to restore function (SCI rehabilitation) should be based on the success of rigorous clinical trials with demonstrated effective interventions. Knowing the course of neurological recovery, its mechanism, and its measures will be essential in designing and executing these trials. We reviewed selected recovery outcomes and measures from multicenter studies and a large SCI database. The accuracy of baseline examinations in the first days following injury is critical to demonstrating changes in neurological recovery. Recovery of one neurologic level in subjects with tetraplegia depends on the severity of the injury, the initial level of the injury, and the strength of muscles below the level of injury. Motor recovery of the upper limbs typically correlates with self-care function. Neurological recovery following SCI often correlates with an increase in function and walking in addition to self-care. In subjects with paraplegia, predicting recovery of walking is possible based on the initial 1-week sensory and motor examination. Although initial neurological findings correlate with neurological and functional-recovery outcomes in large populations of 3,500 subjects reported by the Model SCI System centers in the United States, improved outcome measures for walking are needed. The Walking Index for Spinal Cord Injury (WISCI) has recently demonstrated criterion validity and increased sensitivity and responsiveness to change in neurological/walking function in subjects with SCI. The WISCI scale correlated well with measures in use to determine improved walking function regarding walking speed, lower-limb motor scores, and other measures. Demonstrating improved neurologic and functional outcomes following SCI requires accurate neurologic and sensitive functional measures.
authors.affiliation: Department of Rehabilitation Medicine, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA. John.Ditunno@jefferson.edu
authors.forename: John F
authors.initials: JF
authors.lastname: Ditunno
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Burns
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Marino
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003943:Diagnostic Techniques, Neurological; D006801:Humans; D017063:Outcome Assessment, Health Care; D020127:Recovery of Function; D013119:Spinal Cord Injuries / Q000503:physiopathology / Q000534:rehabilitation*; D016896:Treatment Outcome