Overground Robotic Exoskeleton Gait Training in People With Incomplete Spinal Cord Injury During Inpatient Rehabilitation: A Randomized Control Trial.

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<.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=.008 and P<.001, respectively) and the usual care group improved in SCIM (P=.002) only. For AIS D, both groups improved in the WISCI-II, 10MWT, and SCIM (all P<.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.