Stroke, IschemicNCT06494202
Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
A study testing Innovative rehabilitation and Conventional rehabilitation program. in people with Stroke, Ischemic, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Innovative rehabilitation and Conventional rehabilitation program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
São Paulo, 04101-300
About this study
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?
Read more
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
- Being tested
- Innovative rehabilitation, Conventional rehabilitation program.
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative rehabilitationOther
Conventional rehabilitation program associated with innovative therapies.
Conventional rehabilitation program.Other
Conventional rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: Innovative rehabilitation; Other: Conventional rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to six weeks of intervention.
Secondary outcomes (9)
Functional independence
Functional independence measured with Functional Independence Measure (FIM). This scale ranges from 18 to 126, and higher scores mean better outcomes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to six weeks of intervention.
Gait recovery
Gait recovery measured with 10-meter walk test (10mwt).
Measured: Change from baseline to six weeks of intervention.
Gait and balance recovery
Gait and balance recovery measured with Timed Up and Go (TUG).
Measured: 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.
Measured: 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.
Measured: Change from baseline to six weeks of intervention.
Sensibilization assessment
Sensibilization assessment conducted with Pain Pressure Threshold (PPT).
Measured: Change from baseline to six weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, Professor, Principal investigator, Instituto de Medicina Física e Reabilitação - FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494202
- Sponsor's protocol ID
- 78062224.5.0000.0068
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System
- ClinicalTrials.gov ID
- NCT06494202
- Acronym / sponsor ID
- 78062224.5.0000.0068
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation program | Active comparator | Other: 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 | Experimental | Other: Innovative rehabilitation, Other: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- Presence of psychiatric disorders;
- Presence of subarachnoid hemorrhage;
- Presence of intracerebral hemorrhage;
- Presence of neuromuscular disorders;
- Presence of other neurological diseases or brain neoplasm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innovative rehabilitationConventional rehabilitation program associated with innovative therapies. | Other | Innovative rehabilitation program |
| Conventional rehabilitation program.Conventional rehabilitation program | Other | Conventional rehabilitation program, Innovative rehabilitation program |
Primary outcome
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.
9 secondary outcomes
Functional independence
Time frame: Change from baseline to six weeks of intervention.
Muscle strength
Time frame: Change from baseline to six weeks of intervention.
Upper extremity recovery
Time frame: Change from baseline to six weeks of intervention.
Spasticity reduction
Time frame: Change from baseline to six weeks of intervention.
Gait recovery
Time frame: Change from baseline to six weeks of intervention.
Gait and balance recovery
Time frame: Change from baseline to six weeks of intervention.
Pain assessment
Time frame: Change from baseline to six weeks of intervention.
Quality of life after stroke
Time frame: Change from baseline to six weeks of intervention.
Sensibilization assessment
Time frame: Change from baseline to six weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Imamura, Professor principal investigator
Instituto de Medicina Física e Reabilitação - FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative rehabilitation and Conventional rehabilitation program. in people with Stroke, Ischemic, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Imamura, Professor (55-11-5180-8017, marta.imamura@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor recovery (time frame: Change from baseline to six weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.