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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Other: Conventional rehabilitation program.; Other: Innovative rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Imamura, Professor; Phone Number: 55-11-5180-8017; Email: marta.imamura@fm.usp.br
• Study Contact Backup: Name: Artur Santos; Phone Number: 55-11-5180-8017; Email: artur.santos@hc.fm.usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 04101-300
    • Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Conventional rehabilitation program.; Conventional rehabilitation program
Experimental: Innovative 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).	Other: Conventional rehabilitation program.; Conventional rehabilitation program; Other: Innovative rehabilitation; Conventional rehabilitation program associated with innovative therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor recovery	Motor recovery measured with Fugl-Meyer Assessment (FMA), ranging from 0 to 100 for upper and lower extremities combined. Higher scores mean better outcome.	Change from baseline to six weeks of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional independence	Functional independence measured with Functional Independence Measure (FIM). This scale ranges from 18 to 126, and higher scores mean better outcomes.	Change from baseline to six weeks of intervention.
Muscle strength	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.	Change from baseline to six weeks of intervention.
Upper extremity recovery	Finger movement measured with Finger Tapping assessement. The finger tapping assessment measures the number index finger movements (up and down) performed for one minute.	Change from baseline to six weeks of intervention.
Spasticity reduction	Upper limbs spasticity measured with Modified Ashworth Scale (MAS). The MAS ranges from 0 to 4, and higher scores mean worse outcomes.	Change from baseline to six weeks of intervention.
Gait recovery	Gait recovery measured with 10-meter walk test (10mwt).	Change from baseline to six weeks of intervention.
Gait and balance recovery	Gait and balance recovery measured with Timed Up and Go (TUG).	Change from baseline to six weeks of intervention.
Pain assessment	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.	Change from baseline to six weeks of intervention.
Quality of life after stroke	Quality of Life after stroke measured with Stroke Impact Scale (SIS). The SIS ranges from 0 to 100 and higher scores mean better outcomes.	Change from baseline to six weeks of intervention.
Sensibilization assessment	Sensibilization assessment conducted with Pain Pressure Threshold (PPT).	Change from baseline to six weeks of intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural control	Postural control measured with pressure platforms combined with static activities and cognitive activities.	Change from baseline to six weeks of intervention.
Body Mass Index (BMI)	BMI measured with weight and height and the widely known formula.	Baseline
Physical activity	Physical activity fitness tested with exercise bike.	Change from baseline to six weeks of intervention.
Sarcopenia	Sarcopenia determined with a combination of handgrip strength, sit-to-stand, and ultrasonography.	Baseline
Ancestrality	Role of ancestrality in the outcome measures. A blood sample will be used for this outcome.	Baseline.
Genetic polymorphisms	Role of genetic polymorphism the outcome measures. A blood sample will be used for this outcome.	Baseline.
Physical Activity	Level of physical activity measured with 3-D accelerometer (ActigraphwGT3x-BT ).	Baseline.
Nutritional status	Nutritional status described with nutrition questionnaire. The questionnaire ranges from 0 to 100 and higher scores mean better outcomes.	Baseline.
Stool assessment	Stool classification based on Bristol Stool Scale. This scale classifies the feces into seven Types. Types 3 and 4 indicate good better outcomes and the extremities of this classification indicate worse outcomes.	Baseline
Excessive daytime sleepiness	Excessive daytime sleepiness measured with Epworth Sleepiness Scale. This scale ranges from 0 to 24 and higher scores mean worse outcome.	Change from baseline to six weeks of intervention.
Sleep quality assessment - Questionnaire	Sleep quality measured with Pittsburgh Sleep Quality Index. This is a scale that ranges from 0 to 21 and higher scores indicate worse outcome.	Change from baseline to six weeks of intervention.
Sleep quality assessment - digital assessment	Sleep quality measured with digital actigraphy.	Change from baseline to six weeks of intervention.
Handgrip strength	Handgrip strength measured with dynamometer.	Change from baseline to six weeks of intervention.
Lower limb muscle strength	Lower limb muscle strength measured with Sit-to-stand test.	Baseline
Muscle thickness	Lower limb muscle thickness assessed with ultrasound of the vastus intermedius muscle.	Baseline

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Marta Imamura, Professor, Instituto de Medicina Física e Reabilitação - FMUSP

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 78062224.5.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Study data will be made available under reasonable request after publication. Data will include de-identified participant data and the data dictionary. Requests can be submitted to the corresponding author. Request will be analyzed and ethical and legal implications of data sharing will be considered. Data will be shared after consent of study participants

Brazil is under Brazilian General Data Protection Law (LGPD, English translation) and all shared data will require participants prior consent.

• IPD Sharing Time Frame: After publication under reasonable request.
• IPD Sharing Access Criteria: Reasonable request and participants prior consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No