A framework to standardize gait study protocols in Parkinson's disease

Background: Research over the past twenty years has shown that gait outcomes have a high sensitivity for diagnosing Parkinson's disease (PD), for detecting the effects of interventions, and for monitoring disease progression, even in early disease. However, the lack of standardization in protocols and reported gait measures is impeding data aggregation across study sites and contributes to heterogeneity in the results, thus limiting the adoption of gait outcomes in clinical trials. Objective: To provide recommendations for a minimum set of gait measures to be adopted in projects evaluating people with PD to enhance standardization across the field. Methods: The Gait Advisors Leading Outcomes for Parkinson's (GALOP) committee is an advisory committee for the MJFF. Based on a five-step approach, GALOP generated recommendations for standardizing protocols that assess quantitative gait measures, following expert consensus on best practices. Results: Built on the literature and consensus amongst experts, we recommend a minimum set of meta-data to accompany gait protocols and a minimum gait assessment protocol to be performed at a comfortable speed. Suggestions on challenging testing are provided. Conclusions: To support and empower the scientific community, we have generated recommendations to collect and share gait data gathered from people with PD using an open data repository. Standardizing gait protocols and outcomes in PD has the potential of accelerating research and clinical trials, harmonizing protocols across study sites, fostering collaborations, and in the long run, improving patient care and quality of life.