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

December 12, 2007 updated by: Reha Rheinfelden

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • AG
      • Rheinfelden, AG, Switzerland, 4310
        • Reha Rheinfelden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dextro-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.
Placebo Comparator: 2
Other: Glucose

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reha Rheinfelden

Investigators

  • Principal Investigator: Thierry M. Ettlin, Prof., Reha Rheinfelden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000/001
  • 2000/030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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