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Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

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ClinicalTrials.gov Identifier: NCT01016119
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : March 8, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Folrex Drug: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
Drug: Placebo
Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
Experimental: Folrex
In this group we will use Folrex cream, in the early rehabilitations in the upper extremity
Drug: Folrex
Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation


Outcome Measures

Primary Outcome Measures :
  1. 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). [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Barthel index [ Time Frame: 4 weeks ]
  2. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016119


Locations
Cuba
Salvador Allende Hospital
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
More Information

Responsible Party: Jose Luis Giroud Benítez, MINSAP
ClinicalTrials.gov Identifier: NCT01016119     History of Changes
Other Study ID Numbers: CAT-0915-CU
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases