Using gait robotics to improve symptoms of Parkinson’s disease: an open-label, pilot randomized controlled trial

BACKGROUND: People with Parkinson’s Disease (PD) have difficulty participating in exercise. AIM: The primary objective of this pilot randomized controlled trial (RCT) was to determine if 8 weeks (2x per week) of bilateral exoskeleton (Exo) exercise results in positive changes in cognition and participation in adults with PD compared to exercising without an exoskeleton (Nxo) or wait-list control (Con). DESIGN: Open-label, parallel, pilot randomized controlled trial. SETTING: Neurorehabilitation clinic in a large urban center. POPULATION: Adults 50-85 years old with a confirmed diagnosis of PD. METHODS: Eight weeks of twice-weekly combined aerobic, strength and mobility exercise or wait-list control. Participants were randomly assigned to exercise with no exoskeleton (Nxo), exercise with the exoskeleton (Exo), or waitlist control (Con). Primary endpoints were change in cognitive function (SCOPA-COG) and mood. Secondary endpoints were change in gait speed, six-minute walk test (6MWT), freezing of gait, balance, and PD-specific health and quality of life outcomes. Safety endpoint was analysis of adverse events (AE). RESULTS: Forty participated in the trial (Exo, N.=13; Nxo, N.=14; Con, N.=13). Significant improvement in the Memory & Learning domain of the SCOPA-COG (P=0.014) and 6MWT (P=0.008) were detected for the Exo group compared to the Nxo and/or Con group. No other statistically significant between-groups effects were found. There were no serious or unanticipated AE. CONCLUSIONS: Functional exercise with a low-profile overground exoskeleton showed promising results for improving memory and gait endurance in people with PD across HY stages I-IV. CLINICAL REHABILITATION IMPACT: Exoskeletons can improve participation in high-intensity exercise.