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

Abstract

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.