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Journal of Neurology

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Open Access 01-04-2018 | Original Communication

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

Authors: D. Ferrazzoli, P. Ortelli, G. Riboldazzi, R. Maestri, G. Frazzitta

Published in: Journal of Neurology | Issue 4/2018

Abstract

Background

Dopamine Replacement Therapy (DRT) represents the most effective treatment for Parkinson’s disease (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.

Objective

To evaluate the synergism between DRT and rehabilitation in treating 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.

Materials and 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 (R). The primary outcome measure was the total score of Unified Parkinson’s Disease Rating Scale (UPDRS). The secondary outcomes included the UPDRS sub-sections II and III (UPDRS II-III), the 6-Minute Walk Test (6MWT), the Timed Up and Go Test (TUG) and the amount of Rotigotine. Patients were evaluated at baseline (T0), 6 months (T1), 1 year (T2), and at 18 months (T3).

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.

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.

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Title: 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
Authors: D. Ferrazzoli
P. Ortelli
G. Riboldazzi
R. Maestri
G. Frazzitta
Publication date: 01-04-2018
Publisher: Springer Berlin Heidelberg
Published in: Journal of Neurology / Issue 4/2018
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI: https://doi.org/10.1007/s00415-018-8792-0

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

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

Background

Objective

Materials and methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Objective

Materials and methods

Results

Conclusions

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