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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
Reha Rheinfelden
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 12, 2007
Last Updated
December 12, 2007
Sponsor
Reha Rheinfelden
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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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