Clinical trial NCT06494202: Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
Official title: Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2024-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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).

Primary outcomes:
measure: Motor recovery
timeFrame: Change from baseline to six weeks of intervention.
Secondary outcomes:
measure: Functional independence
timeFrame: Change from baseline to six weeks of intervention.
measure: Muscle strength
timeFrame: Change from baseline to six weeks of intervention.
measure: Upper extremity recovery
timeFrame: Change from baseline to six weeks of intervention.
measure: Spasticity reduction
timeFrame: Change from baseline to six weeks of intervention.
measure: Gait recovery
timeFrame: Change from baseline to six weeks of intervention.
measure: Gait and balance recovery
timeFrame: Change from baseline to six weeks of intervention.
measure: Pain assessment
timeFrame: Change from baseline to six weeks of intervention.
measure: Quality of life after stroke
timeFrame: Change from baseline to six weeks of intervention.
measure: Sensibilization assessment
timeFrame: Change from baseline to six weeks of intervention.
Other outcomes:
measure: Physical Activity
timeFrame: Baseline.
measure: Postural control
timeFrame: Change from baseline to six weeks of intervention.
measure: Nutritional status
timeFrame: Baseline.
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Stool assessment
timeFrame: Baseline
measure: Excessive daytime sleepiness
timeFrame: Change from baseline to six weeks of intervention.
measure: Sleep quality assessment - Questionnaire
timeFrame: Change from baseline to six weeks of intervention.
measure: Sleep quality assessment - digital assessment
timeFrame: Change from baseline to six weeks of intervention.
measure: Physical activity
timeFrame: Change from baseline to six weeks of intervention.
measure: Handgrip strength
timeFrame: Change from baseline to six weeks of intervention.
measure: Sarcopenia
timeFrame: Baseline
measure: Lower limb muscle strength
timeFrame: Baseline
measure: Muscle thickness
timeFrame: Baseline
measure: Ancestrality
timeFrame: Baseline.
measure: Genetic polymorphisms
timeFrame: Baseline.
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
Study officials:
affiliation: Instituto de Medicina Física e Reabilitação - FMUSP
name: Marta Imamura, Professor
role: PRINCIPAL_INVESTIGATOR
References: