Evidence map›Paper›PMID 29442177›Full record

Trial reportJournal of neurology2018

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

Erratum issuedOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Journal of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

D FerrazzoliDepartment of Parkinson's Disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital-Via Pelascini 3, Gravedona ed Uniti (CO), 22015, Como, Italy. davideferrazzoli@gmail.com.
P OrtelliDepartment of Parkinson's Disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital-Via Pelascini 3, Gravedona ed Uniti (CO), 22015, Como, Italy.
G RiboldazziParkinson's Disease and Movement Disorders Center, ASST dei Sette Laghi, Varese, Italy.
R MaestriDepartment of Biomedical Engineering, Istituti Clinici Scientifici Maugeri Spa Società Benefit, IRCCS, Via per Montescano 3, Montescano, 27040, Pavia, Italy.
G FrazzittaDepartment of Parkinson's Disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital-Via Pelascini 3, Gravedona ed Uniti (CO), 22015, Como, Italy.
Moriggia Pelascini Hospital · ITIstituti Clinici Scientifici Maugeri · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDopamine 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.

objectiveTo 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

methodsIn 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).

resultsNo 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.

conclusionsOver 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.

Indexed as

Exercise TherapyGoalsAgedAnalysis of VarianceDopamine AgonistsFemaleFollow-Up StudiesHumansMaleMiddle AgedOutcome Assessment, Health CareParkinson DiseaseSingle-Blind MethodTetrahydronaphthalenesThiophenesTime FactorsDopamine AgonistsrotigotineTetrahydronaphthalenesThiophenesDopamine agonistsDRT-related side effectsMultidisciplinary careParkinson’s diseaseRehabilitation

Identifiers

PMID29442177
PMCPMC5878188
OpenAlexW2791120996

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.