Validity of the walking scale for spinal cord injury and other domains of function in a multicenter clinical trial.

OBJECTIVE To demonstrate criterion (concurrent and predictive) and construct validity of the Walking Index for Spinal Cord Injury (WISCI) scale and other walking measures in the Spinal Cord Injury Locomotor Trial (SCILT). DESIGN Prospective multicenter clinical trial of a walking intervention for patients with acute traumatic spinal cord injury (SCI). PARTICIPANTS/ METHODS: Body weight-supported treadmill training was compared to overground mobility training in 146 patients with incomplete SCI (C4 to L3) enrolled within 8 weeks of onset and treated for 12 weeks. Primary outcome measures were the Functional Independence Measure (FIM), 50-foot walking speed (50FW-S), and 6-minute walking distance (6MW-D), tested 3, 6, and 12 months after entry. Secondary measures were the Lower Extremity Motor Score (LEMS), Berg Balance Scale (BBS), WISCI, and FIM locomotor score (LFIM), assessed at 6 centers by blinded observers. Data for the 2 arms were combined since no significant differences in outcomes had been found. RESULTS Correlations with WISCI at 6 months were significant with BBS (r = .90), LEMS (r = .85), LFIM (r = .89), FIM (r = .77), 50FW-S (r = .85), and 6MW-D ( r = .79); similar correlations occurred at 3 and 12 months. Correlations of change scores from baseline WISCI were significant for change scores from baseline of LEMS/BBS/LFIM. Correlation of baseline LEMS and WISCI at 12 months were most significant (r = .73). The R(2) of baseline LEMS explained 57% of variability of WISCI levels at 3 months. CONCLUSION Concurrent validity of the WISCI scale was supported by significant correlations with all measures at 3, 6, and 12 months. Correlation of change scores supports predictive validity. The LEMS at baseline was the best predictor of the WISCI score at 12 months and explained most of the variance, which supported both predictive and construct validity. The combination of the LEMS, BBS, WISCI, 50FW-S, and LFIM appears to encompass adequate descriptors for outcomes of walking trials for incomplete SCI.