Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
  • Folrex Drug
    Intervention Desc: Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
    ARM 1: Kind: Experimental
    Label: Folrex
    Description: In this group we will use Folrex cream, in the early rehabilitations in the upper extremity

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 Yes
Secondary Barthel index 4 weeks Yes
Secondary National Institutes of Health Stroke Scale (NIHSS) 4 weeks No

Sponsors