Tuesday, August 9, 2022

ENHANCEMENT OF STROKE REHABILITATION WITH LEVODOPA (ESTRELSTUDY) - DESIGN AND PROGRESS OF THE ONGOING MULTICENTER PLACEBO CONTROLLED RANDOMIZED TRIAL

Just why was this research needed? You're so fucking incompetent you didn't know of all this earlier research? I'd fire the lot of you.

 ENHANCEMENT OF STROKE REHABILITATION WITH LEVODOPA (ESTRELSTUDY) - DESIGN AND PROGRESS OF THE ONGOING MULTICENTER PLACEBO CONTROLLED RANDOMIZED TRIAL 

European Stroke Journal ; 7(1 SUPPL):162-163, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-1928085

Background:

In this multicenter, randomized, placebo-controlled trial we study whether Levodopa given in addition to usual rehabilitative therapies is associated with a patient-relevant enhancement of motor recovery after acute stroke.

Methods:

ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a multicenter, placebo-controlled randomized superiority trial. Patients with an acute ischemic or hemorrhagic stroke ≤7 days leading to a clinically meaningful hemiparesis in need of in-hospital rehabilitation are enrolled in stroke units and later transferred to experienced neurorehabilitation centers. Participants receive Levodopa 100mg/Carbidopa 25mg three times daily or matching placebo for 5 weeks in addition to standardized rehabilitative therapy. The primary outcome is the Fugl-Meyer- Motor Assessment score 3 months after randomization. We present the characteristics of the first 200 of 610 patients to be enrolled.

Results:

13 certified stroke units and 13 neurorehabilitation centers are involved (“stroke-pathway-trial”). The first 200 participants had a median age of 73 [IQR 64-82] years and 43.5 % were female. 169 patients (84.5%) had ischemic stroke. At baseline, the median NIH-Stroke scale score was 8 [5-10]. Successful 3-month assessment was performed in 183 patients (91.5%);11 (5%) died, 5 (2.5%) withdrew from the study and 1 patient missed the clinical 3 months-visit due to the COVID-19 pandemic.

Conclusions:

The ESTREL study will provide evidence whether the additional use of Levodopa in the rehabilitation process of stroke patients is safe and effective. The ESTREL-study started successfully due to the good cooperation between acute stroke units and rehabilitation centers, as well as the high acceptance rate among patients.

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