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

ISRCTN	ISRCTN88489864
DOI	https://doi.org/10.1186/ISRCTN88489864
Secondary identifying numbers	NTR220

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr H.I. van Genderen
Scientific

P.O. Box 310
Enschede
7500 AH
Netherlands

Phone	+31 (0)53 487 5765
Email	h.vangenderen@rrd.nl

Study design	Randomised double blind placebo controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Ischaemic stroke
Intervention	Single administration of 20 mg of fluoxetine, or placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fluoxetine
Primary outcome measure	Muscle activation patterns, measured by electromyogram (EMG).
Secondary outcome measures	1. Grip strength 2. Motricity Index 3. Delay times
Overall study start date	11/03/2004
Completion date	01/11/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	10
Key inclusion criteria	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.
Key exclusion criteria	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
Date of first enrolment	11/03/2004
Date of final enrolment	01/11/2004

P.O. Box 310

Enschede
7500 AH
Netherlands

Roessingh Research and Development (Netherlands)
Hospital/treatment centre

Roessingh Rehabilitation Centre
P.O. Box 310
Enschede
7500 AH
Netherlands

Research organisation

Euregio - INTERREG IIIA programme (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan