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Effectiveness of Rotigotine plus Intensive and Goal-based Rehabilitation versus Rotigotine alone in “de-novo” Parkinsonian subjects: A Randomized Controlled Trial with 18-month Follow-up

D. Ferrazzoli, P. Ortelli, G. Riboldazzi, R. Maestri, G. Frazzitta (Gravedona ed Uniti, Italy)

Meeting: 2018 International Congress

Abstract Number: 279

Keywords: Dopamine agonists, Rehabilitation

Session Information

Date: Saturday, October 6, 2018

Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment

Session Time: 1:45pm-3:15pm

Location: Hall 3FG

Objective: To evaluate the synergism between Dopamine Replacement Therapy (DRT) and rehabilitation in treating Parkinson’s disease (PD), by investigating the short and the long-term effectiveness of a multidisciplinary, intensive and goal-based rehabilitation treatment (MIRT) in a group of patients treated with rotigotine.

Background: DRT represents the most effective treatment for PD. Nevertheless, several symptoms are unresponsive to treatment and its long-term use leads to serious side effects. To optimize the pharmacological management of PD, dopamine-agonists are often prescribed to de novo patients. Moreover, several studies have shown the effectiveness and the synergic effect of rehabilitation in treating PD.

Methods: In this multicenter, single blinded, parallel-group, 1:1 allocation ratio, randomized, non-inferiority trial, 36 de novo PD patients were evaluated along 18 months: 17 were treated with Rotigotine plus MIRT; 19 were treated with Rotigotine alone.

Results: No differences in UPDRS scores in the two groups (total score, III part and II part, p=0.48, p=0.90 and p=0.40, respectively) were found in the time course. Conversely, a greater improvement in Rotigotine+MIRT group was observed for 6MWT (p<0.0001) and TUG (p=0.03). Along time, the dosage of Rotigotine was higher in patients who did not undergo MIRT, at all observation times following T0. Considering the entire study period (T3 vs T0), we found in the Rotigotine group a direct correlation between DRT dosage and improvements in total UPDRS and UPDRS III (r=0.48, p=0.04 and r=0.61, p=0.005 respectively), but we did not find a direct correlation with the motor performances evaluated with 6MWT (p=0.19) and TUG (p=0,45) scores. Considerably, no correlation was observed for patients in the experimental group who gained better results in motor performances.

Conclusions: Over the course of 18 months, the effectiveness of the combined treatment (Rotigotine+MIRT) on the patients’ global clinical status, evaluated with total UPDRS, was not inferior to that of the pharmacological treatment with Rotigotine alone. Importantly, rehabilitation allowed patients to gain better motor performances with lower DRT dosage. These results could be interpreted as a clear example of a good synergism between DRT use and rehabilitative efforts.

References: Frazzitta G, Maestri R, Bertotti G, Riboldazzi G, Boveri N, Perini M, Uccellini D, Turla M, Comi C, Pezzoli G, Ghilardi MF (2015) Intensive rehabilitation treatment in early Parkinson’s disease: a randomized pilot study with a 2-year follow-up. Neurorehabil Neural Repair 29:123–131. doi: 10.1177/1545968314542981. Scheller D, Stichel-Gunkel C, Lübbert H, Porras G, Ravenscroft P, Hill M, Bezard E (2008) Neuroprotective effects of rotigotine in the acute MPTP-lesioned mouse model of Parkinson’s disease. Neurosci Lett 432:30-34.

To cite this abstract in AMA style:

D. Ferrazzoli, P. Ortelli, G. Riboldazzi, R. Maestri, G. Frazzitta. Effectiveness of Rotigotine plus Intensive and Goal-based Rehabilitation versus Rotigotine alone in “de-novo” Parkinsonian subjects: A Randomized Controlled Trial with 18-month Follow-up [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/effectiveness-of-rotigotine-plus-intensive-and-goal-based-rehabilitation-versus-rotigotine-alone-in-de-novo-parkinsonian-subjects-a-randomized-controlled-trial-with-18-month-follow/. Accessed May 13, 2025.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/effectiveness-of-rotigotine-plus-intensive-and-goal-based-rehabilitation-versus-rotigotine-alone-in-de-novo-parkinsonian-subjects-a-randomized-controlled-trial-with-18-month-follow/

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