Objective: To provide recommendations for a minimum set of gait outcome measures to be adopted in projects evaluating people with Parkinson’s disease (PD).

Background: Gait impairments strongly influence quality of life in PD. Currently, clinical trials in PD are limited by the low sensitivity of gold-standard, outcome measures that are subjective, and usually consist of qualitative clinical rating scales that require expertise. Research from the past twenty years on gait has shown high sensitivity for diagnosis in early disease, effects of interventions, and monitoring disease progression. However, the lack of standardization in protocols and reported gait measures is impeding data aggregation across centers and contributes to heterogeneity in the results, thus limiting the adoption of gait outcomes in clinical trials.

Method: The Gait Advisors Leading Outcomes for Parkinson’s (GALOP) committee is an advisory committee for the Michael J. Fox Foundation for Parkinson’s Research (MJFF). The committee comprises a person with PD living with gait issues and experts in the field, from academia and clinical care, who aim to progress research and treatment of gait impairments in PD. GALOP is leading the effort in generating a set of recommendations for the standardization of protocols assessing quantitative gait measures following best practice to be used as consensus guidelines in prospective gait studies.

Results: We recommend a minimum set of meta-data to accompany gait protocols (including basic demographics and MoCA assessment), and a minimum gait protocol, depicted in Figure 1, to be performed at a comfortable speed. In addition, we also recommend adding additional challenging conditions such as fast pace walking or dual tasking to enable a comprehensive assessment of mobility. Investigators should specify the used technology to collect quantitative gait outcomes and provide a data dictionary. The minimum set of gait measures is reported in Figure 1.

Conclusion: This work will be integrated into research programs addressing gait impairment selected for funding by MJFF. Our objective is to support the scientific community by generating recommendations to collect and share gait data gathered from people with PD using an open data repository. Our long-term goal of standardizing gait protocols and outcomes in PD has the potential of accelerating research and clinical trial results, harmonizing protocols across centers and fostering collaborations.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-framework-to-standardize-gait-study-protocols-in-parkinsons-disease/