Measurements and Recovery Patterns in a Multicenter Study of Acute Spinal Cord Injury

Abstract

The prognosis of these patients with spinal cord injury seen at 28 centers in North America during the mid-1990s appears better than was often assumed earlier. The general patterns are similar across different measurement scales, although there are intriguing differences. The patterns in different strata are different in specifics, and complete injuries do less well. Pooling data from different strata may result in probability distributions that depart from normal-theory assumptions and give misleading results depending on recruitment patterns.

Effects on age on spinal cord lesion patients' rehabilitation

“…Both Penrod et al 12 and Burns et al 14 took into account patients with only incomplete tetraplegia and in both studies patients were first evaluated within 1 week from the lesion, while our patients were evaluated in average 50-60 days after the lesion. It has been reported recently that a great amount of recovery in spinal cord injury patients occurs within 2 months from the injury, 25 thus it is possible that by the time our patients have been admitted to our hospital, a part of the recovery already occurred. Furthermore, in our series some ASIA A and B patients reached independent walking with appropriate braces and devices, but only in the young group.…”

“…24 Patients who improved their ASIA impairment grade, however, had a significant lower LTA interval (47 days) as compared to those subjects, who did not improve (73 days). Since the most marked improvement of incomplete injuries occurs in the first two months, 25 comparisons where LTA is not controlled may be invalid.…”

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

“…Over the past 2 decades, a small number of major SCI clinical trials have been undertaken and completed, including investigations of the neuroprotective benefits of Methylprednisolone, 1-5 GM-1 (Sygen), 6,7 and Gacyclidine (GK-11). 8 Each of these trials provided valuable data that has been most useful to the ICCP Clinical Guidelines Panel.…”

“…We have addressed this by re-analysing some of the data from the control group and the combined control and treatment groups of the largest and most detailed trial of a treatment for spinal injury yet attempted, the Sygen trial. 6,7 A challenge encountered by the panel is that the data have generally not been presented in a format that relates to the probable recovery patterns that are anticipated for many of the treatments currently being contemplated. The current and upcoming SCI clinical trials focus on neuroprotection, axonal regeneration, promotion of neural plasticity or a combination of these mechanisms.…”

“…Three large, double-blind, placebocontrolled pharmaceutical trials focussed on acute neuroprotection and rehabilitation in SCI are reported in the literature; the National Acute Spinal Cord Injury Study (NASCIS), Sygen and GK-11 trials. [2][3][4][5][6][7][8] The data from the placebo-control groups in these studies allow the natural history of recovery from injury to be examined within the context of a randomized controlled trial (RCT). In addition, there have been a number of studies of long-term outcomes after SCI that provide valuable information on expected recovery rates, [10][11][12] as well as some recently unpublished data from the European Multicenter study in Spinal Cord Injury (EMSCI).…”