OBJECTIVE: To examine the efficacy of a stakeholder-informed overground robotic exoskeleton (ORE) intervention to improve walking function after spinal cord injury (SCI) compared with usual care gait training. DESIGN: Randomized Controlled Trial. SETTING: Inpatient Rehabilitation Facility. PARTICIPANTS: Patients (N = 106; age 51.5 +/- 18.5y; men 78.3%; White 65.1%) with subacute incomplete SCI. INTERVENTIONS: ORE compared with usual care gait training approaches including body-weight support treadmill training and traditional overground modalities. MAIN OUTCOME MEASURES: Our primary outcome was walking performance defined by function (Walking Index for Spinal Cord Injury-Revised (WISCI-II)) and gait speed (10-m walk test (10MWT)). Secondary outcomes were functional independence (Spinal Cord Independence Measure (SCIM) and CARE Tool) and patient-reported outcomes of pain, fatigue, spasticity, depression, anxiety, and quality of life. RESULTS: Patients were tetraplegia (56.6%) and ASIA Impairment Scale (AIS) B (17.9%), AIS C (28.3%), and AIS D (53.8%). Although improvement was observed in both the ORE and usual care groups across WISCI-II, 10MWT, and SCIM measures (all p < 0.001), there were no significant differences between ORE and usual care gait training on primary and secondary outcomes. Injury severity distinctions were observed for AIS C where the ORE group improved in WISCI-II and SCIM (p = 0.008 and p < 0.001, respectively) and the usual care group improved in SCIM (p = 0.002) only. For AIS D, both groups improved in the WISCI-II, 10MWT, and SCIM (all p < 0.001). Moderate effects sizes between ORE and usual care gait training were detected for transfer and walking CARE Tool items for people with AIS C injuries. CONCLUSIONS: Corollary to our overall equivalence findings between ORE and usual care gait training, ORE may be a more appropriate gait training intervention for patients with AIS C to promote recovery of walking function during inpatient rehabilitation.

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