NCT06494202Not yet recruiting
Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- Stroke
- NCT number
- NCT06494202
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Medicina Física e Reabilitação (IMREA-FMUSP) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.