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ISRCTN
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ISRCTN88489864
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ClinicalTrials.gov identifier
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Public title
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Influence of a single dose of fluoxetine on muscle activation patterns and functional ability in chronic stroke patients
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR220
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Study hypothesis
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A single dose of fluoxetine influences muscle activation patterns and functional ability of the muscles in the lower part of the upper extremity in chronic stroke patients.
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Lay summary
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Ethics approval
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Received from the local medical ethics committee
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Study design
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Randomised double blind placebo controlled crossover trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Ischaemic stroke
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Participants - inclusion criteria
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The participating patients suffered a single ischemic stroke (confirmed by CT-scan or MRI-scan) more than six months before the start of the trial, they were over 18 years of age. Furthermore, they were able to perform some selective movements with the paretic wrist (MRC 2). And were able to follow the instructions they were given.
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Participants - exclusion criteria
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1. Patients suffering from an other neurological disease
2. Uncompensated hemineglect or cognitive disabilities, resulting in misunderstanding or incapability of executing instructions given
3. Epilepsy, or first epileptic insult post stroke
4. Patients with first grade relatives suffering epilepsy
5. Pregnancy
6. Pacemaker
7. State after irritation or lesion of median nerve
8. Implanted pumps to administer medicines
9. Metal parts inside the head
10.Cerebral aneurysm-clips (metal inside)
11. Uncontrolled medical problems
12. Alcoholism or drug-use
13. Pathological heart rhythm disorders
14. Raised intracerebral pressure (hydrocephalus)
15. External catheter
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Anticipated start date
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11/03/2004
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Anticipated end date
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01/11/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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10
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Interventions
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Single administration of 20 mg of fluoxetine, or placebo.
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Primary outcome measure(s)
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Muscle activation patterns, measured by electromyogram (EMG).
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Secondary outcome measure(s)
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1. Grip strength
2. Motricity Index
3. Delay times
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Sources of funding
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Euregio - INTERREG IIIA programme (Netherlands)
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Trial website
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Publications
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Contact name
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Dr
H.I.
van Genderen
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Address
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P.O. Box 310
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City/town
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Enschede
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Zip/Postcode
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7500 AH
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Country
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Netherlands
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Tel
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+31 (0)53 487 5765
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Fax
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+31 (0)53 434 0849
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Email
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h.vangenderen@rrd.nl
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Sponsor
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Roessingh Research and Development (Netherlands)
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Address
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Roessingh Rehabilitation Centre
P.O. Box 310
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City/town
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Enschede
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Zip/Postcode
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7500 AH
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Country
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Netherlands
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Email
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m.ijzerman@rrd.nl
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Sponsor website:
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http://www.rrd.nl/
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Date applied
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20/12/2005
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Last edited
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15/05/2009
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Date ISRCTN assigned
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20/12/2005
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