Enhancement of Stroke Rehabilitation With Levodopa
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Stroke
- Stroke Rehabilitation
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study participants will be randomized 1:1Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Trial investigates whether Levodopa/Carbidopa compared to placebo given in addition to standardized rehabilitative therapy in patients with acute stroke is associated with a) patient relevant improvements of physical function b) improvement in patient-self assessed general health aspects, pain, mood...
Trial investigates whether Levodopa/Carbidopa compared to placebo given in addition to standardized rehabilitative therapy in patients with acute stroke is associated with a) patient relevant improvements of physical function b) improvement in patient-self assessed general health aspects, pain, mood, anxiety, fatigue and social participation c) long-term sustainability of a patient-relevant improvement of motor function d) improvement of selective hand and wrist movement e) a higher rate of patients walking independently of the help of another person. f) less severe impairment g) a higher level of activity of daily living h) improvements of quality of life (i) better cognitive performance (j) no signals of harms (i.e. indications for increased all-cause mortality, recurrent stroke or serious adverse events).
Tracking Information
- NCT #
- NCT03735901
- Collaborators
- Swiss National Science Foundation
- Investigators
- Principal Investigator: Stefan Engelter, Prof. MD Felix-Platter Spital Basel
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