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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Motor recovery [Срок оценки: Change from baseline to six weeks of intervention.]

Вторичные конечные точки (9)

• Functional independence [Срок оценки: Change from baseline to six weeks of intervention.]
• Muscle strength [Срок оценки: Change from baseline to six weeks of intervention.]
• Upper extremity recovery [Срок оценки: Change from baseline to six weeks of intervention.]
• Spasticity reduction [Срок оценки: Change from baseline to six weeks of intervention.]
• Gait recovery [Срок оценки: Change from baseline to six weeks of intervention.]
• Gait and balance recovery [Срок оценки: Change from baseline to six weeks of intervention.]
• Pain assessment [Срок оценки: Change from baseline to six weeks of intervention.]
• Quality of life after stroke [Срок оценки: Change from baseline to six weeks of intervention.]
• Sensibilization assessment [Срок оценки: Change from baseline to six weeks of intervention.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 1 центр

• Instituto de Medicina Física e Reabilitação (IMREA-FMUSP) — São Paulo

Идентификаторы

NCT: NCT06494202 · 78062224.5.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗