Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025/10298-4 | Other Grant/Funding Number | São Paulo Research Foundation (FAPESP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ribeirão Preto Medical School, University of São Paulo | UNKNOWN |
| Clinical Hospital, Ribeirão Preto Medical School, University of São Paulo | UNKNOWN |
| University of California, Los Angeles | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to provide preliminary evidence of whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone in Brazil. Evaluate the safety and feasibility of telerehabilitation in the Brazilian context. Explore the clinical, neuroimaging, neurophysiological, and economic factors that influence telerehabilitation efficacy in functional recovery following stroke.
This is a two-arm phase II randomized controlled trial with blinded outcome assessment. A total of 20 post-stroke participants will be randomized to either telerehabilitation added to usual care (TR+UC) or usual care alone (UC). The primary outcome measure is the Action Research Arm Test (ARAT), which assesses upper extremity motor function. Secondary measures will include feasibility and intervention-related outcomes.
Study participation will span approximately 4 months and includes 6 in-person assessment visits. At these visits, participants will complete a battery of assessments, including upper extremity motor function tests, resting-state functional electroencephalography (EEG), and a single magnetic resonance imaging (MRI) scan of the brain. Participants assigned to the TR+UC group will receive structured arm motor training consisting of 36 sessions of prescribed exercises, interactive games, and stroke education delivered over 6 weeks at a frequency of 6 days per week, with each session lasting approximately 70 minutes. TR+UC participants will continue all usual care concurrently. Participants in the UC group will continue all therapies recommended by their medical team without participating in telerehabilitation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. |
|
| Telerehabilitation + Usual Care | Active Comparator | In addition to the usual care, patients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Device | Participants will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. | Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function. | From baseline to early (within 7 days) post-intervention |
| Study feasibility in the Brazilian context - recruitment. | Proportion of eligible participants who agree to take part in the study. | Through recruitment completion - an average of 15 months |
| Study feasibility in the Brazilian context - adherence. | Proportion of participants who complete TR therapy with sessions of 40 minutes or longer. | Through study completion (specifically end of therapy) - an average of 17 months |
| Study feasibility in the Brazilian context - retention. | Proportion of dropouts during the study participation period. | Through study completion (specifically end of follow-up) - an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. | Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function. | From baseline to 1 month post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| White matter integrity assessed using diffusion tensor imaging (DTI) magnetic resonance imaging (MRI). | Cortical spinal tract integrity - lesion load (predictive factor). | Baseline |
| Interhemispheric connectivity of motor cortices assessed using resting-state functional magnetic resonance imaging (rs-fMRI). |
Inclusion Criteria:
Exclusion Criteria:
22. Availability of a 2 m² space for a table and chair setup.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taiza G. S. Edwards, PhD | Contact | +5516-36021202 | trbr1@usp.br | |
| Antonio Carlos Santos, MD, PhD | Contact | +551636022964 |
| Name | Affiliation | Role |
|---|---|---|
| Taiza G. S. Edwards, PhD | Ribeirão Preto Medical School, University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribeirão Preto Medical School, University of São Paulo | Recruiting | Ribeirão Preto | São Paulo | 14049900 | Brazil |
Non-PHI data will be shared with appropriate parties after the study is completed and published.
Anytime after July, 2028.
Appropriate parties with appropriate intention for use of the data, starting 07/01/2028, with access to PHI-free data.
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
| Thomas Jefferson University | OTHER |
| Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School | UNKNOWN |
Participants are randomized to TR + usual care (intervention) or usual care alone (control)
Not provided
Not provided
Statistician.
|
| Usual Care | Other | Usual care rehabilitation refers to the recommendations made by their care team. |
|
| Treatment-related adverse events reported by the participants. | Number and severity of adverse events related to the telerehabilitation intervention reported by the participants. | From the start of TR to early (within 7 days) post-intervention |
rs-fMRI interhemispheric functional connectivity in the primary motor cortex (predictive factor). |
| Baseline |
| Motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS). | nTMS motor mapping (predictive factor). | Baseline |
| Interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG). | rsEEG interhemispheric functional connectivity in the primary motor cortex (predictive factor). | Baseline |
| Change in upper-extremity Fugl-Meyer assessment (UE-FM) from baseline to the early post-intervention. | Change in UE-FM. UE-FM is a scale that measures upper limb motor function using a scale that runs from 0 to 66 points, with higher scores reflecting better upper extremity motor function. | From baseline to early (within 7 days) post-intervention |
| Change in Modified Rankin Scale (mRS) from Baseline to the early post-intervention. | Change in mRS. The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function. | From baseline to early (within 7 days) post-intervention |
| Change in interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG). | Change in rsEEG interhemispheric functional connectivity in the primary motor cortex. | From baseline to early (within 7 days) post-intervention |
| Change in interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG). | Change in rsEEG interhemispheric functional connectivity in the primary motor cortex. | From baseline to 1-month post-intervention |
| Change in motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS) from baseline to early post-intervention. | nTMS motor mapping (predictive factor). | From baseline to early (within 7 days) post-intervention |
| Change in motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS) from baseline to 1 month post-intervention. | nTMS motor mapping (predictive factor). | From baseline to 1 month post-intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |