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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