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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovative rehabilitation | Other | Conventional rehabilitation program associated with innovative therapies. |
|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Level of physical activity measured with 3-D accelerometer (ActigraphwGT3x-BT ). | Baseline. |
| Postural control | Postural control measured with pressure platforms combined with static activities and cognitive activities. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Marta Imamura, Professor | Instituto de Medicina FÃsica e Reabilitação - FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina FÃsica e Reabilitação (IMREA-FMUSP) | São Paulo | 04101-300 | Brazil |
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.
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After publication under reasonable request.
Reasonable request and participants prior consent.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Different collaborators will be care providers and outcomes assessors.
| Conventional rehabilitation program. | Other | Conventional rehabilitation program |
|
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. |
| Change from baseline to six weeks of intervention. |
| Nutritional status | Nutritional status described with nutrition questionnaire. The questionnaire ranges from 0 to 100 and higher scores mean better outcomes. | Baseline. |
| Body Mass Index (BMI) | BMI measured with weight and height and the widely known formula. | 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. |
| Physical activity | Physical activity fitness tested with exercise bike. | Change from baseline to six weeks of intervention. |
| Handgrip strength | Handgrip strength measured with dynamometer. | Change from baseline to six weeks of intervention. |
| Sarcopenia | Sarcopenia determined with a combination of handgrip strength, sit-to-stand, and ultrasonography. | Baseline |
| 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 |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |