Stroke
Conditions
Keywords
randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke
Brief summary
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).
Interventions
DRUGDextro-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.
OTHERGlucose
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.
Sponsors
Reha Rheinfelden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chedoke-McMaster Stroke Assessment (motor impairment measure) | Over the whole duration of the study (2001 to 2006, ten times for each patient) |
Countries
Switzerland
Outcome results
None listed