search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Influence of a single dose of fluoxetine on muscle activation patterns and functional ability in chronic stroke patients.


- candidate number1390
- NTR NumberNTR220
- ISRCTNISRCTN88489864
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsN/A 
- Public TitleInfluence of a single dose of fluoxetine on muscle activation patterns and functional ability in chronic stroke patients.
- Scientific TitleInfluence of a single dose of fluoxetine on muscle activation patterns and functional ability in chronic stroke patients.
- ACRONYMN/A
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedIschemic stroke
- Inclusion criteriaThe 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 intructions they were given.
- Exclusion criteria1. 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 poststroke;
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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-mrt-2004
- planned closingdate1-nov-2004
- Target number of participants10
- InterventionsSingle administration of 20 mg of fluoxetine, or placebo.
- Primary outcomeMuscle activation patterns, measured by EMG.
- Secondary outcomeGrip strength, Motricity Index, Delay times.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. H.I. Genderen, van
- CONTACT for SCIENTIFIC QUERIES M.J. IJzerman
- Sponsor/Initiator Rehabilitation Centre 'The Roessingh' Enschede
- Funding
(Source(s) of Monetary or Material Support)
Euregio, INTERREG IIIA-program
- PublicationsN/A
- Brief summaryBy conducting a cross-over, placebo-controlled study with 10 chronic stroke patients, it was found that a single dose of fluoxetine does non-selectively increase muscle activation of the upper limb in these patients. Although no equivalent effects were found for fluoxetine on motor function.
- Main changes (audit trail)
- RECORD5-sep-2005 - 16-jun-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl