Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
NCT Number: NCT06494202
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: OTHER: Innovative rehabilitation|OTHER: Conventional rehabilitation program.
Sponsor: University of Sao Paulo
Collaborators: Ministry of Health, Brazil
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Instituto de Medicina Física e Reabilitação (IMREA-FMUSP), São Paulo, 04101-300, Brazil

Summary:
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.

Primary Outcome Measures: 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., Change from baseline to six weeks of intervention.
Secondary Outcome Measures: Functional independence, Functional independence measured with Functional Independence Measure (FIM). This scale ranges from 18 to 126, and higher scores mean better outcomes., 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., 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., 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., Change from baseline to six weeks of intervention.|Gait recovery, Gait recovery measured with 10-meter walk test (10mwt)., Change from baseline to six weeks of intervention.|Gait and balance recovery, Gait and balance recovery measured with Timed Up and Go (TUG)., 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., 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., Change from baseline to six weeks of intervention.|Sensibilization assessment, Sensibilization assessment conducted with Pain Pressure Threshold (PPT)., Change from baseline to six weeks of intervention.
Other Outcome Measures: Physical Activity, Level of physical activity measured with 3-D accelerometer (ActigraphwGT3x-BT )., Baseline.|Postural control, Postural control measured with pressure platforms combined with static activities and cognitive activities., Change from baseline to six weeks of intervention.|Nutritional status, Nutritional status described with nutrition questionnaire. The questionnaire ranges from 0 to 100 and higher scores mean better outcomes., Baseline.|Body Mass Index (BMI), BMI measured with weight and height and the widely known formula., Baseline|Stool assessment, Stool classification based on Bristol Stool Scale. This scale classifies the feces into seven Types. Types 3 and 4 indicate good better outcomes and the extremities of this classification indicate worse outcomes., Baseline|Excessive daytime sleepiness, Excessive daytime sleepiness measured with Epworth Sleepiness Scale. This scale ranges from 0 to 24 and higher scores mean worse outcome., Change from baseline to six weeks of intervention.|Sleep quality assessment - Questionnaire, Sleep quality measured with Pittsburgh Sleep Quality Index. This is a scale that ranges from 0 to 21 and higher scores indicate worse outcome., Change from baseline to six weeks of intervention.|Sleep quality assessment - digital assessment, Sleep quality measured with digital actigraphy., Change from baseline to six weeks of intervention.|Physical activity, Physical activity fitness tested with exercise bike., Change from baseline to six weeks of intervention.|Handgrip strength, Handgrip strength measured with dynamometer., Change from baseline to six weeks of intervention.|Sarcopenia, Sarcopenia determined with a combination of handgrip strength, sit-to-stand, and ultrasonography., Baseline|Lower limb muscle strength, Lower limb muscle strength measured with Sit-to-stand test., Baseline|Muscle thickness, Lower limb muscle thickness assessed with ultrasound of the vastus intermedius muscle., Baseline|Ancestrality, Role of ancestrality in the outcome measures. A blood sample will be used for this outcome., Baseline.|Genetic polymorphisms, Role of genetic polymorphism the outcome measures. A blood sample will be used for this outcome., Baseline.