Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
NCT ID: NCT00572767
Last Updated: 2007-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
16 participants
INTERVENTIONAL
2001-01-31
2006-09-30
Brief Summary
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Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.
The outcome measure focuses on motor recovery and will be assessed:
* one and two weeks before study intervention (baseline phase)
* five times during the study intervention
* one week after study intervention (follow-up)
* once after six and twelve months after start of the study intervention (follow-up).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dextro-Amphetamin
After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
2
Glucose
After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
The treatment of the control group will be the same as for the experimental group except the content of the drug capsule.
Interventions
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Dextro-Amphetamin
After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
Glucose
After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
The treatment of the control group will be the same as for the experimental group except the content of the drug capsule.
Eligibility Criteria
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Inclusion Criteria
* correlation of clinical symptoms with a brain imaging (CT or MRI)
* able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
* start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
* older than 13 years
* given written informed consent (or two independent witnesses)
Exclusion Criteria
* any additional neurological or psychiatric illnesses
* instable arrythmia
* not controlled or treated arterial hypertension
* ensured cardioembolic event
* anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
* certain anticonvulsiva or antihypertonica
* manifest hyperthyreosis
* dementia or terminal illnesses
* epilepsy, phaeochromocytoma or glaucoma
* women known to be pregnant or lactating
18 Years
ALL
No
Sponsors
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Reha Rheinfelden
OTHER
Responsible Party
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Reha Rheinfelden
Principal Investigators
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Thierry M. Ettlin, Prof.
Role: PRINCIPAL_INVESTIGATOR
Reha Rheinfelden
Locations
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Reha Rheinfelden
Rheinfelden, Canton of Aargau, Switzerland
Countries
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References
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Schuster C, Maunz G, Lutz K, Kischka U, Sturzenegger R, Ettlin T. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. doi: 10.1177/1545968311405674. Epub 2011 Jun 28.
Other Identifiers
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2000/030
Identifier Type: -
Identifier Source: secondary_id
2000/001
Identifier Type: -
Identifier Source: org_study_id