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 |
| Protocol serial number | NTR220 |
| Sponsor | Roessingh Research and Development (Netherlands) |
| Funder | Euregio - INTERREG IIIA programme (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Dr H.I. van Genderen
Scientific
Scientific
P.O. Box 310
Enschede
7500 AH
Netherlands
| Phone | +31 (0)53 487 5765 |
|---|---|
| h.vangenderen@rrd.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure(s) |
Muscle activation patterns, measured by electromyogram (EMG). |
| Key secondary outcome measure(s) |
1. Grip strength |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 310
Enschede
7500 AH
Netherlands
7500 AH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
