Robotic walking for recovery of functional capacity in individuals with incomplete spinal cord injury: A randomized pilot trial

Abstract

Abstract Objective Activity-based Training (ABT) represents the current standard of neurological rehabilitation. Robotic Locomotor Training (RLT) is an innovative technique that aims to enhance rehabilitation outcomes, however, its efficacy in SCI rehabilitation, particularly within a low-middle income setting, is currently unclear. The primary aim of this study was to determine the feasibility of a locomotor training program within XX, in terms of recruitment, attendance, drop-out rates and safety. Secondary aims were to determine the effects of RLT compared to ABT on functional capacity in people with chronic SCI. Design Participants with chronic traumatic motor incomplete tetraplegia (n = 16) were recruited. Each intervention involved 60-minute sessions, 3x per week, over 24-weeks. RLT involved walking in the Ekso GT™ suit. ABT involved a combination of resistance, cardiovascular and weight-bearing exercise. Primary feasibility outcomes included recruitment rate, adherence rate, and adverse events. Validated tests were performed at baseline, 6, 12 and 24-weeks to assess the secondary outcomes of functional capacity. Results Out of 110 individuals who expressed interest in participating in the study, 17 initiated the program (recruitment rate = 15.4 %). Of these, 16 individuals completed the program (drop-out rate = 5.8 %) and attended sessions (attendance rate = 93.9%). There were no significant differences between the intervention groups for lower or upper extremity motor scores (UEMS effect size (ES) = 0.09; LEMS ES = 0.05), back strength (ES = 0.14) and abdominal strength (ES = 0.13) after training. However, both groups showed a significant increase of 2.00 points in UEMS and a significant increase in abdominal strength from pre- to post intervention. Only the RLT group showed a significant change in LEMS, with a mean increase of 3.00 [0.00; 16.5] points over time. Distance walked in the Functional Ambulatory Inventory (SCI-FAI) increased significantly (p = 0.02) over time only for the RLT group. Conclusions Recruitment, attrition and adherence rates of the intervention and outcomes justify a subsequent powered RCT comparing RLT to ABT as an effective rehabilitation tool for potentially improving functional strength and walking capacity in people with incomplete SCI.