Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Dextro-Amphetamin
Glucose
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke
Eligibility 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
Sites / Locations
- Reha Rheinfelden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Chedoke-McMaster Stroke Assessment (motor impairment measure)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00572767
Brief Title
Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
Intended length of study ended
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Reha Rheinfelden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dextro-Amphetamin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Glucose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chedoke-McMaster Stroke Assessment (motor impairment measure)
Time Frame
Over the whole duration of the study (2001 to 2006, ten times for each patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry M. Ettlin, Prof.
Organizational Affiliation
Reha Rheinfelden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
AG
ZIP/Postal Code
4310
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21712481
Citation
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.
Results Reference
derived
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Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
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