Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
NCT ID: NCT06494202
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-01
2026-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Conventional rehabilitation program
Conventional rehabilitation intervention with multidisciplinary team (medical services, physiotherapy, occupational therapy, physical education, psychology, nutrition, social service, speech therapy, and nurse) delivered during four to six weeks of intensive in-patient program
Conventional rehabilitation program.
Conventional rehabilitation program
Innovative rehabilitation program
Conventional rehabilitation intervention with multidisciplinary team (medical services, physiotherapy, occupational therapy, physical education, psychology, nutrition, social service, speech therapy, and nurse) delivered during four to six weeks of intensive in-patient program combined with innovative medical therapies (laser therapy, radial extracorporeal shockwaves therapy, focused extracorporeal shockwaves therapy, segmentary desensibilization with lidocaine, functional electrical stimulation - FES).
Innovative rehabilitation
Conventional rehabilitation program associated with innovative therapies.
Conventional rehabilitation program.
Conventional rehabilitation program
Interventions
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Innovative rehabilitation
Conventional rehabilitation program associated with innovative therapies.
Conventional rehabilitation program.
Conventional rehabilitation program
Eligibility Criteria
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Inclusion Criteria
* Single episode of stroke;
* Clinical stability according to medical assessment;
* Time since stroke onset no longer than 24 months;
* Capacity to understand the study procedures;
* Eligible to be admitted to hospitalization at the institute where the study will be conducted
* Agree to sign the Informed Consent Form (ICF).
Exclusion Criteria
* Presence of subarachnoid hemorrhage;
* Presence of intracerebral hemorrhage;
* Presence of neuromuscular disorders;
* Presence of other neurological diseases or brain neoplasm;
* Presence of cognitive disorders measured with Montreal Cognitive Assessment (MoCA), scores below 20 points;
* Presence of systemic arterial hypertension (systolic blood pressure ≥ 185mmHg or diastolic blood pressure ≥ 110 mmHg).
18 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Marta Imamura
MD
Principal Investigators
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Marta Imamura, Professor
Role: PRINCIPAL_INVESTIGATOR
Instituto de Medicina Física e Reabilitação - FMUSP
Locations
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Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
São Paulo, , Brazil
Countries
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Central Contacts
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Other Identifiers
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78062224.5.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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