Stroke is a leading cause of disability and the second leading cause of death worldwide. Most strokes are ischemic, caused by acute arterial occlusion. Post-stroke treatment focuses on secondary prevention and rehabilitation, but few treatments address functional recovery. Creatine, a supplement known for improving physical performance, may aid in the recovery of stroke patients, reducing sarcopenia and improving strength among other effects. This pilot study will investigate the effectiveness of creatine supplementation in enhancing physical and functional recovery in ischemic stroke patients. The study will involve a randomized, double-blind clinical trial comparing creatine monohydrate to a placebo.
Age between 18 and 80 years
Recent diagnosis of ischemic stroke (from 24 hours to 5 days) .
Neurological deficit due to the stroke that affects mobility (paresis and/or ataxia) and requires motor rehabilitation.
Ability to understand and sign the informed consent form, or failing that, have sufficient support to carry out the correct follow-up of the study.
Moderate-severe disability prior to stroke, defined by an mRS>2.
Unstable or severe clinical situation that prevents active rehabilitation.
Neurological deficit due to stroke that prevents walking without help from another person. The use of support with a cane, crutch or walker is permitted.
Moderate or severe dysphagia that makes therapeutic adherence difficult.
Parallel
Creatine monohydrate
Dietary supplementCreatine monohydrate. Guinama brand with CE marking. Code 89823.
Placebo
Other interventionDextrinomaltose. Guinama brand with CE marking. Code 91146.
Physical performance
To analyze the improvement in physical performance, at 3 months (at the end of the intervention) and at 6 months, measured by the 6-Minute Walking Test (6MW).
Physical performance using Test "timed up and go" (TUG).
Test "timed up and go" (TUG).
Maximum muscle strength
Maximum muscle strength, measured by manual dynamometer (Kilograms). Grip strength, biceps, triceps, deltoids, psoas, quadriceps and hamstrings will be assessed.
Arm and leg muscle strength
Measured by the score on items 5 and 6 of the National institute of Health Stroke Scale (NIHSS) where the score range is from 0 to 4. A higher score corresponds to a worse performance.
Balance and stability
Balance and stability measured using the Postural Assessment Scale for Stroke Patients (PASS). The scale includes 12 items, which are divided into two categories: maintaining a posture (static balance) and changing a posture (dynamic balance). Higher scores indicate better postural control and balance.
Click on the lead sponsor to view all of their trials.
Fundació d'investigació Sanitària de les Illes Balears
Lead sponsor
Comunidad Autónoma de las Islas Baleares (Dirección General de Investigación en Salud, Formación y Acreditación)
Collaborator
