Enhanced training protocol improves concurrent validity of CLA Insight wireless inclinometry for lumbar range of motion assessment: A 317-participant validation study
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Objective:
The purpose of this study was to evaluate the concurrent validity and test-retest reliability of CLA Insight wireless inclinometry for lumbar range of motion (ROM) assessment compared with dual inclinometry and to assess whether enhanced training protocols improve measurement accuracy.
Methods:
This prospective validation study enrolled 317 adults with chronic low back pain (86 initial cohort, 231 subsequent cohort following enhanced training). Participants underwent same-day lumbar ROM assessment using both CLA wireless inclinometry (2 trials) and dual inclinometry in 4 directions (flexion, extension, lateral bending). Concurrent validity was assessed using intraclass correlation coefficients (ICC[3,1]) and Bland-Altman analysis. Test-retest reliability compared trial 1 vs trial 2 measurements.
Results:
In the combined data set, CLA demonstrated excellent concurrent validity (ICC = 0.929; 95% confidence interval [CI], 0.900-0.950; r = 0.886; P < .001) with minimal bias (-1.59°) and acceptable 95% limits of agreement (-10.27° to 7.08°). Enhanced training improved validity from good (ICC = 0.709) in the initial cohort to excellent (ICC = 0.992) in the subsequent cohort, representing a clinically meaningful enhancement in measurement agreement. Test-retest reliability was excellent (ICC = 0.974; MDC95 = 3.87°). Manual clinical estimates showed poor agreement with objective measurements, overestimating ROM by 17°-19°. Over 12-month follow-up, flexion ROM improved by +11.24° (P < .001), and the composite CORESCORE neurological index improved significantly from 64.9 to 73.3 (paired-t P < .001).
Conclusion:
CLA Insight wireless inclinometry demonstrates excellent concurrent validity and test-retest reliability for lumbar ROM assessment when combined with standardized training protocols. Enhanced training significantly improves measurement accuracy, providing an implementation framework for clinical adoption.