Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System

NCT06494202 · tracked via the Priya Life Science Brazil tracker

Sponsor

University of Sao Paulo

Phase

Not applicable

Started

2024-10-01

Last updated

2024-07-31

Condition(s) studied

Stroke, Ischemic

Investigational drug(s) / intervention(s)

Innovative rehabilitationConventional rehabilitation program.

Innovative rehabilitation: Conventional rehabilitation program associated with innovative therapies.

Conventional rehabilitation program.: Conventional rehabilitation program

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Clinical and radiological (magnetic resonance or tomography) diagnosis of ischemic stroke; * 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 psychiatric disorders; * 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).

Primary outcome measure(s)

Motor recovery — Change from baseline to six weeks of intervention.
Motor recovery measured with Fugl-Meyer Assessment (FMA), ranging from 0 to 100 for upper and lower extremities combined. Higher scores mean better outcome.

Trial sites (1)

Facility	City	Region	Status
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)	São Paulo	Brazil

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06494202 on ClinicalTrials.gov ↗ ← All trials in Brazil