Objective: To determine if outcomes following a PT program are improved if PT sessions are conducted while PD patients are in an on motor state vs. an end-of-dose off motor state.

Background: It is well established that exercise and PT have an immediate and potentially long-term impact on motor functions in PD patients. However, to date, most PT studies have not addressed the role that DA replacement therapy and/or motor state may contribute to enhancing the practice of the PT intervention and thus its functional outcomes. Published studies in animal models of DA depletion support the role of DA replacement in facilitating motor learning. The purpose of this study is to examine whether the benefits of PT are greater when patients are undergoing PT training in the on state vs. the off state.

Methods: PERFORM is an ongoing multicenter, outpatient study to evaluate PT outcomes in PD patients currently using apomorphine (APO) injections to manage motor fluctuations. Patients are randomized (1:1) to 2 treatment groups (Group 1: PT sessions conducted with patients in an on state with APO & Group 2: PT sessions conducted with patients in an end-of-dose off state). All patients will arrive for the PT visit in an end-of-dose off state (no PD medications in prior 3 hours) and will participate in a standardized PT intervention (3 visits/week to a total of 18 visits). To ensure that PD patients in Group 1 are in the on state during each PT training period, a subcutaneous injection of their usual dose of APO will be administered a few minutes prior to each session. Use of rescue therapy is prohibited during the PT visits. The primary endpoint is the mean change from baseline to study end in the Activities-specific Balance Confidence Scale (ABC) total score. Secondary outcome measures include: MDS-UPDRS (Parts 1, 2, 3 and 4) scores, Modified Physical Performance Test, Timed Up & Go, 6 minute walk, Montreal Cognitive Assessment, and Clinical Global Impressions of Severity and Change.

Results: The study was initiated in November 2015, with a planned enrollment of 100 patients. Results are expected Q3 2016.

Conclusions: PERFORM is one of the first studies to prospectively address the role of the motor state in PT training and outcomes.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/perform-controlled-study-in-fluctuating-pd-patients-examining-the-effects-of-motor-state-on-the-outcomes-resulting-from-a-structured-physical-therapy-pt-program/