The goal of this clinical trial is to systemize and hierarchize a rehabilitation program for the Brazilian Unified Health System in patients with stroke above 18 years of age and of both sexes. The main question it aims to answer is: * Do patients with ischemic first episode of stroke have central nervous systems consequences due to peripheral and central nervous system sensibilization? * Can stroke patients benefit from a systemized and hierarchized rehabilitation program with desensibilization interventions combined with multidisciplinary and educational programs? We will randomize 60 patients, 30 in each study arm. Researchers will compare the intervention group with an active control whose treatment is the institutional conventional program to see if innovative desensibilization strategies yield superior results. Authors will also investigate the role of genetic polymorphism and ancestrality in the outcome measures. Participants will undertake an innovative or conventional rehabilitation program, according to the randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
60
Conventional rehabilitation program associated with innovative therapies.
Conventional rehabilitation program
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
São Paulo, Brazil
Motor recovery
Motor recovery measured with Fugl-Meyer Assessment (FMA), ranging from 0 to 100 for upper and lower extremities combined. Higher scores mean better outcome.
Time frame: Change from baseline to six weeks of intervention.
Functional independence
Functional independence measured with Functional Independence Measure (FIM). This scale ranges from 18 to 126, and higher scores mean better outcomes.
Time frame: Change from baseline to six weeks of intervention.
Muscle strength
Muscle strength measured Medical Research Council scale (MRC). The MRC is a scale that ranges from 0 to 5 and higher scores mean better outcomes.
Time frame: Change from baseline to six weeks of intervention.
Upper extremity recovery
Finger movement measured with Finger Tapping assessement. The finger tapping assessment measures the number index finger movements (up and down) performed for one minute.
Time frame: Change from baseline to six weeks of intervention.
Spasticity reduction
Upper limbs spasticity measured with Modified Ashworth Scale (MAS). The MAS ranges from 0 to 4, and higher scores mean worse outcomes.
Time frame: Change from baseline to six weeks of intervention.
Gait recovery
Gait recovery measured with 10-meter walk test (10mwt).
Time frame: Change from baseline to six weeks of intervention.
Gait and balance recovery
Gait and balance recovery measured with Timed Up and Go (TUG).
Time frame: Change from baseline to six weeks of intervention.
Pain assessment
Pain intensity measured with Visual Analogue Scale (VAS). The VAS is a linear approximation of pain intensity ranging from 0 to 10 and higher scores mean worse outcomes.
Time frame: Change from baseline to six weeks of intervention.
Quality of life after stroke
Quality of Life after stroke measured with Stroke Impact Scale (SIS). The SIS ranges from 0 to 100 and higher scores mean better outcomes.
Time frame: Change from baseline to six weeks of intervention.
Sensibilization assessment
Sensibilization assessment conducted with Pain Pressure Threshold (PPT).
Time frame: Change from baseline to six weeks of intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.