Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Phase 3
Completed
- Conditions
- Stroke
- Interventions
- Drug: FolrexDrug: Placebo
- Registration Number
- NCT01016119
- Lead Sponsor
- Catalysis SL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Folrex Folrex In this group we will use Folrex cream, in the early rehabilitations in the upper extremity Placebo Placebo In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Barthel index 4 weeks National Institutes of Health Stroke Scale (NIHSS) 4 weeks
Trial Locations
- Locations (1)
Salvador Allende Hospital
🇨🇺Havana City, Havana, Cuba