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

NCT06494202 | Not Yet Recruiting DMC

• 1 other identifier: 78062224.5.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Functional independence

  Change from baseline to six weeks of intervention.

• Muscle strength

  Change from baseline to six weeks of intervention.

• Upper extremity recovery

  Change from baseline to six weeks of intervention.

• Spasticity reduction

  Change from baseline to six weeks of intervention.

• Gait recovery

  Change from baseline to six weeks of intervention.

Other Outcomes (15)

• Physical Activity

  Baseline.

• Postural control

  Change from baseline to six weeks of intervention.

• Nutritional status

  Baseline.

Study Arms (2)

Conventional rehabilitation program

ACTIVE COMPARATOR

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.

Innovative rehabilitation program

EXPERIMENTAL

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: Innovative rehabilitation; Other: Conventional rehabilitation program.

Interventions

Innovative rehabilitation OTHER

Conventional rehabilitation program associated with innovative therapies.

Innovative rehabilitation program

Conventional rehabilitation program. OTHER

Conventional rehabilitation program

Conventional rehabilitation program; Innovative rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

São Paulo, 04101-300, Brazil

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marta Imamura, Professor

  Instituto de Medicina Física e Reabilitação - FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Imamura, Professor

CONTACT

55-11-5180-8017; marta.imamura@fm.usp.br

Artur Santos

CONTACT

55-11-5180-8017; artur.santos@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Different collaborators will be care providers and outcomes assessors.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

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

Locations

BR (1)