Clinical outcomes of rehabilitation with a robotic anthropomorphic exoskeleton in patients with motor-incomplete spinal cord injury: a multicenter randomized controlled trial

BACKGROUND: Robotic exoskeletons offer a promising tool for gait rehabilitation in individuals with spinal cord injury (SCI). However, evidence of their additive benefit over conventional therapy, particularly in non-acute, motor-incomplete SCI, remains limited. AIM: exoskeleton, used in an "add-on" mode, on walking performance and related clinical outcomes compared to standard neurorehabilitation alone. DESIGN: Randomized, controlled, multicenter trial. SETTING: Rehabilitation centers. METHODS: Thirty-six patients with chronic, motor-incomplete SCI (AIS C/D, 1-5 years post-injury) were randomized to receive either 4 weeks of exoskeleton-assisted training followed by 4 weeks of standard rehabilitation (RC+E), or 8 weeks of standard rehabilitation alone (RC). The primary outcome was the proportion of participants achieving ≥ 10% improvement in walking speed (10-meter walk test) at 4 weeks. Secondary outcomes included gait endurance, muscle strength, spasticity, proprioception, pain and mood. RESULTS: At 4 weeks, 33.3% of RC+E vs. 46.7% of RC patients improved in walking speed (P=0.44); at 8 weeks, 43.8% vs. 66.7%, respectively (P=0.20). No significant between-group differences were found for any outcome, including endurance, strength, or pain. Both groups demonstrated clinically relevant within-group improvements over time. No adverse events occurred. CONCLUSIONS: exoskeleton was safe and well-tolerated, but did not show a superior statistical effect on walking performance compared with conventional rehabilitation when delivered as a short-term add-on intervention. These findings should be interpreted within the context of the study and small sample size. Continued structured rehabilitation remains essential for functional maintenance and improvement in this population. CLINICAL REHABILITATION IMPACT: While robotic exoskeletons are feasible and safe in chronic SCI rehabilitation, their routine use as a short-term add-on to standard therapy may not yield additional functional benefits under the tested conditions. Emphasis should remain on comprehensive, individualized rehabilitation programs tailored to patient-specific needs. Larger, adequately powered studies are needed to confirm these findings.