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OpenTrials
Completed

NCT Number: NCT01016119

Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

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.

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Salvador Allende Hospital

Havana, La Habana, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Folrex

Drug

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

Placebo

Drug

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

Primary outcomes

  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 outcomes

  1. Barthel index

    Time frame: 4 weeks

  2. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2009
Registry last updated
Mar 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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