The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.
The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent
Born Preventive Healthcare Clinic, PC
Grand Rapids, Michigan, United States
Schachter Center for Complementary Medicine
Suffern, New York, United States
Comprehensive Heart Care Inc.
Toledo, Ohio, United States
Barthel Index
Time frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions
Improvement in muscle strength and function
Time frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions
Change in the Mini-mental status examination
Time frame: Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions
Change in balance, coordination, range of motion
Time frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions
Incidence of adverse events and changes in vital signs
Time frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions
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