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NCT Number: NCT06494202

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

São Paulo, 04101-300, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Innovative rehabilitation

Other

Conventional rehabilitation program associated with innovative therapies.

Conventional rehabilitation program.

Other

Conventional rehabilitation program

Primary outcomes

  1. Motor recovery

    Time frame: 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 outcomes

  1. Functional independence

    Time frame: 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.

  2. Muscle strength

    Time frame: 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.

  3. Upper extremity recovery

    Time frame: 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.

  4. Spasticity reduction

    Time frame: 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.

  5. Gait recovery

    Time frame: Change from baseline to six weeks of intervention.

    Gait recovery measured with 10-meter walk test (10mwt).

  6. Gait and balance recovery

    Time frame: Change from baseline to six weeks of intervention.

    Gait and balance recovery measured with Timed Up and Go (TUG).

  7. Pain assessment

    Time frame: 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.

  8. Quality of life after stroke

    Time frame: 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.

  9. Sensibilization assessment

    Time frame: Change from baseline to six weeks of intervention.

    Sensibilization assessment conducted with Pain Pressure Threshold (PPT).

Other outcomes

  1. Physical Activity

    Time frame: Baseline.

    Level of physical activity measured with 3-D accelerometer (ActigraphwGT3x-BT ).

  2. Postural control

    Time frame: Change from baseline to six weeks of intervention.

    Postural control measured with pressure platforms combined with static activities and cognitive activities.

  3. Nutritional status

    Time frame: Baseline.

    Nutritional status described with nutrition questionnaire. The questionnaire ranges from 0 to 100 and higher scores mean better outcomes.

  4. Body Mass Index (BMI)

    Time frame: Baseline

    BMI measured with weight and height and the widely known formula.

  5. Stool assessment

    Time frame: Baseline

    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.

  6. Excessive daytime sleepiness

    Time frame: Change from baseline to six weeks of intervention.

    Excessive daytime sleepiness measured with Epworth Sleepiness Scale. This scale ranges from 0 to 24 and higher scores mean worse outcome.

  7. Sleep quality assessment - Questionnaire

    Time frame: Change from baseline to six weeks of intervention.

    Sleep quality measured with Pittsburgh Sleep Quality Index. This is a scale that ranges from 0 to 21 and higher scores indicate worse outcome.

  8. Sleep quality assessment - digital assessment

    Time frame: Change from baseline to six weeks of intervention.

    Sleep quality measured with digital actigraphy.

  9. Physical activity

    Time frame: Change from baseline to six weeks of intervention.

    Physical activity fitness tested with exercise bike.

  10. Handgrip strength

    Time frame: Change from baseline to six weeks of intervention.

    Handgrip strength measured with dynamometer.

  11. Sarcopenia

    Time frame: Baseline

    Sarcopenia determined with a combination of handgrip strength, sit-to-stand, and ultrasonography.

  12. Lower limb muscle strength

    Time frame: Baseline

    Lower limb muscle strength measured with Sit-to-stand test.

  13. Muscle thickness

    Time frame: Baseline

    Lower limb muscle thickness assessed with ultrasound of the vastus intermedius muscle.

  14. Ancestrality

    Time frame: Baseline.

    Role of ancestrality in the outcome measures. A blood sample will be used for this outcome.

  15. Genetic polymorphisms

    Time frame: Baseline.

    Role of genetic polymorphism the outcome measures. A blood sample will be used for this outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Artur Santos

CONTACT

[email protected]

55-11-5180-8017

Marta Imamura, Professor

CONTACT

[email protected]

55-11-5180-8017

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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