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

University of Sao Paulo

Status: Not yet enrolling

Conditions: Stroke, Ischemic

Treatments: Other: Innovative rehabilitation; Other: Conventional rehabilitation program.

Study type: Interventional

Funder types: Other

Identifiers

NCT06494202

78062224.5.0000.0068

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Conventional rehabilitation program

Active Comparator group

Description:

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

Treatment:

Other: Conventional rehabilitation program.

Innovative rehabilitation program

Experimental group

Description:

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).

Treatment:

Other: Conventional rehabilitation program.

Other: Innovative rehabilitation