Stroke
Conditions
Brief summary
The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.
Detailed description
Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.
Interventions
DRUGFolrex
Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
DRUGPlacebo
Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with acute stroke \< 24 hours. * Patients with impairment up to 4 on NIHSS scale. * Family support. * Informed consent.
Exclusion criteria
* Presence of another disease not well controlled. * Patient with dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks). | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Barthel index | 4 weeks |
| National Institutes of Health Stroke Scale (NIHSS) | 4 weeks |
Countries
Cuba
Outcome results
None listed