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Not yet recruiting NCT06494202

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

No phase Interventional Stroke, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Innovative rehabilitation, Conventional rehabilitation program..
Who it may be relevant to
Registry conditions: Stroke, Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Innovative rehabilitation
    Conventional rehabilitation program associated with innovative therapies.
  • Other Conventional rehabilitation program.
    Conventional rehabilitation program

Primary outcome measures

  • Motor recovery [Time frame: Change from baseline to six weeks of intervention.]
Secondary outcome measures (9)
  • Functional independence [Time frame: Change from baseline to six weeks of intervention.]
  • Muscle strength [Time frame: Change from baseline to six weeks of intervention.]
  • Upper extremity recovery [Time frame: Change from baseline to six weeks of intervention.]
  • Spasticity reduction [Time frame: Change from baseline to six weeks of intervention.]
  • Gait recovery [Time frame: Change from baseline to six weeks of intervention.]
  • Gait and balance recovery [Time frame: Change from baseline to six weeks of intervention.]
  • Pain assessment [Time frame: Change from baseline to six weeks of intervention.]
  • Quality of life after stroke [Time frame: Change from baseline to six weeks of intervention.]
  • Sensibilization assessment [Time frame: Change from baseline to six weeks of intervention.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

Brazil · 1 center
  • Instituto de Medicina Física e Reabilitação (IMREA-FMUSP) — São Paulo

Identifiers

NCT: NCT06494202 · 78062224.5.0000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗