Robot-assisted locomotor training did not improve walking function in patients with chronic incomplete spinal cord injury: A randomized clinical trial

Abstract

Objective: To assess the effects of robot-assisted locomotor training in patients with chronic incomplete spinal cord injury. Design: Randomized single-blind controlled clinical trial. Setting: The intervention site was an outpatient clinic, and pre- and post-evaluations were performed in a rehabilitation hospital. Patients: A total of 24 subjects with American Spinal Injury Association Impairment Scale grades C or D, > 2 years post-injury. Interventions: Subjects were randomized to 60 days of robot-assisted locomotor training, or to usual care. Methods: Walking function, lower extremity muscle strength and balance were assessed single-blinded pre- and post-intervention. Results: After a 9-year recruitment period, only 24 of the planned 30 subjects had been enrolled (mean time since injury 17 (standard deviation (SD) 20) years for all subjects). Walking function, lower extremity muscle strength and balance improved modestly in both groups, with no statistically significant group difference in walking function or muscle strength, whereas postural control declined significantly in the intervention group, compared with controls (p = 0.03). Conclusion: Late-onset robot-assisted locomotor training did not re-establish independent walking function. A modest, but non-significant, effect was seen on muscle strength and balance. However, significant between-group differences were found only in postural control in the control group.