Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
- Conditions
- Stroke, Ischemic
- Interventions
- Other: Conventional rehabilitation program.Other: Innovative rehabilitation
- Registration Number
- NCT06494202
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional rehabilitation program Conventional rehabilitation program. 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 Innovative rehabilitation program Conventional rehabilitation program. 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). Innovative rehabilitation program Innovative rehabilitation 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).
- Primary Outcome Measures
Name Time Method Motor recovery Change from baseline to six weeks of intervention. Motor recovery measured with Fugl-Meyer Assessment (FMA), ranging from 0 to 100 for upper and lower extremities combined. Higher scores mean better outcome.
- Secondary Outcome Measures
Name Time Method Upper extremity recovery Change from baseline to six weeks of intervention. Finger movement measured with Finger Tapping assessement. The finger tapping assessment measures the number index finger movements (up and down) performed for one minute.
Spasticity reduction Change from baseline to six weeks of intervention. Upper limbs spasticity measured with Modified Ashworth Scale (MAS). The MAS ranges from 0 to 4, and higher scores mean worse outcomes.
Gait recovery Change from baseline to six weeks of intervention. Gait recovery measured with 10-meter walk test (10mwt).
Quality of life after stroke Change from baseline to six weeks of intervention. Quality of Life after stroke measured with Stroke Impact Scale (SIS). The SIS ranges from 0 to 100 and higher scores mean better outcomes.
Functional independence Change from baseline to six weeks of intervention. Functional independence measured with Functional Independence Measure (FIM). This scale ranges from 18 to 126, and higher scores mean better outcomes.
Muscle strength Change from baseline to six weeks of intervention. Muscle strength measured Medical Research Council scale (MRC). The MRC is a scale that ranges from 0 to 5 and higher scores mean better outcomes.
Gait and balance recovery Change from baseline to six weeks of intervention. Gait and balance recovery measured with Timed Up and Go (TUG).
Pain assessment Change from baseline to six weeks of intervention. Pain intensity measured with Visual Analogue Scale (VAS). The VAS is a linear approximation of pain intensity ranging from 0 to 10 and higher scores mean worse outcomes.
Sensibilization assessment Change from baseline to six weeks of intervention. Sensibilization assessment conducted with Pain Pressure Threshold (PPT).
Trial Locations
- Locations (1)
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
🇧🇷São Paulo, Brazil