Completed Research Studies

16. Title: Restoration of Walking After Spinal Cord Injury: Demonstrate the WISCI Scale is More Responsive to Change Than Other Outcome Measures in the Demonstration of Efficacy of Interventions Such as Physical Training in Clinical Trials Experiment 3

Purpose: The purpose of this trial is to determine whether the WISCI scale is more responsive to change than other outcome measures in the demonstration of efficacy of interventions such as physical training in clinical trials.

Principal Investigator: John F. Ditunno, MD
Co-Investigator(s): Michael F. Saulino, MD, Ph.D.

Background: The initial Walking Index for Spinal Cord Injury (WISCI) study, published in 2000, is an international multicenter validity and reliability study developed in collaboration with members of the RSCICDV. A subsequent study by an international panel of SCI experts found the WISCI scale is 100% reliable and measures what it intends to measure (walking).

The WISCI scale may demonstrate improvement of walking function in multicenter clinical trials because of its increased sensitivity and precision. Such an outcome measure should have utility in current and future studies that evaluate pharmacological or medical rehabilitation interventions.To further evaluate the WISCI scale,the RSCICDV has embarked on a subsequent series of studies to validate the WISCI as it applies to patients as they recover from SCI.

In experiment 3, the WISCI scale is being assessed for its responsiveness to change in two multicenter clinical trials and, if possible, the sensitivity to change based on the effectiveness of the interventions in those same clinical trials. The Center has gained permission from the responsible individuals to examine the WISCI data for responsiveness to change and its correlation with other outcome measures.

One study is an National Institutes of Health-funded randomized clinical trial to study locomotor training in spinal cord injury by Body Weight Support Treadmill Training (BWSTT). The WISCI scale is being utilized as a secondary outcome measure. RSCICDV staff will be able to determine responsiveness for those individuals entered by their Center.

The second study is a multicenter drug trial which for which the RSCICDV is the lead center and for which the WISCI scale will be tested to determine if it is an effective outcome measure for a future phase 3 trial.

Status: Study Completed

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