Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

NCT ID: NCT01016119

Last Updated: 2010-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

In this group we will use Placebo cream, in the early rehabilitations in the upper extremity

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Folrex

In this group we will use Folrex cream, in the early rehabilitations in the upper extremity

Group Type: EXPERIMENTAL

Folrex

Intervention Type: DRUG

Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Interventions

Folrex

Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Intervention Type: DRUG

Placebo

Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

MINSAP

Locations

Salvador Allende Hospital

Havana, La Habana, Cuba

Countries

Cuba

Other Identifiers

CAT-0915-CU

Identifier Type: -

Identifier Source: org_study_id