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Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study

ConditionsIschemic Stroke, AcuteRehabilitation OutcomeCerebrolysin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Previous stroke or disability (mRS > 0)

The patient unable to understand instructions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cerebrolysin treatment

    Drug

    The patients will receive Cerebrolysin treatment, 10 days consecutively, 30 ml/day, intravenous infusion diluted up to 100 ml of 0.9% saline in 15 minutes.

  • Standard treatment (including neurorehabilitation) of acute ischemic stroke

    Other intervention

    "Standard treatment" entails acute ischemic stroke reperfusion treatment according to international guidelines and local policies, instituting secondary preventive treatment, a proper management of stroke risk factors and neurorehabilitation according to patient's needs: locomotor physiotherapy, occupation therapy, speech therapy, and neuropsychological assessment.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1: Cerebrolysin GroupExperimental treatment 2 interventions
Group B: Arm 2: Standard treatment only GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

90-day Action Research Arm Test (ARAT) Score change

A standardized test after stroke to measure the function of the upper limb. Range of scores: 0-57, with higher scores meaning a better outcome.

Time frame
90 days post-stroke

Secondary outcomes

1

National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days

NIHSS is standardized in stroke medicine for measuring neurological deficits after stroke; range of scores 0-42, higher scores mean a worse outcome

Time frame
90 days
2

Modified Rankin Score (mRS) at day 90

mRS is a functional global scale measuring the functional disability after stroke, widely accepted in international registries and trials of stroke, range 0-6, with higher scores meaning worse outcome

Time frame
90 days
3

Extended Barthel index (EBI) 90 days post-stroke

EBI measures neurological improvement after stroke in activities of daily living, range 0-100, with higher scores meaning better outcome

Time frame
90 days
4

The De Morton Mobility Index (DEMMI) Score 90 days

Mobility assessment in elderly population, range 0-100, with higher scores meaning a better outcome

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov
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