Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
Information source: Reha Rheinfelden
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke
Intervention: Dextro-Amphetamin (Drug); Glucose (Other)
Phase: Phase 4
Status: Terminated
Sponsored by: Reha Rheinfelden Official(s) and/or principal investigator(s): Thierry M. Ettlin, Prof., Principal Investigator, Affiliation: Reha Rheinfelden
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).
Clinical Details
Official title: Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Chedoke-McMaster Stroke Assessment (motor impairment measure)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Reha Rheinfelden, Rheinfelden, AG 4310, Switzerland
Additional Information
Starting date: January 2001
Last updated: December 12, 2007
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