Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial. 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).

Official Title
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Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Drug: Dextro-Amphetamin
* Other: Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four) 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: intracranial or (chronic) subdural hemorrhages 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dextro-Amphetamin<br>* 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.<br>|
| Placebo Comparator: 2<br> | Other: Glucose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chedoke-McMaster Stroke Assessment (motor impairment measure) |  | Over the whole duration of the study (2001 to 2006, ten times for each patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke