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The objective of this randomized clinical trial is to evaluate the effects of using telerehabilitation (remote care) by occupational therapists on improving the performance and recovery of patients within the Brazilian Unified Health System (SUS) who have suffered a stroke and are on a waiting list for specialized rehabilitation care.
The main question it seeks to answer is:
The researchers compare an experimental group (receiving telerehabilitation treatment) with a waitlist group (which will remain on the waitlist without receiving a specific intervention).
Participants are required to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Participants in this group receive Occupational Therapy guidance via telehealth (telerehabilitation) focused on improving occupational performance. |
|
| Waiting List | No Intervention | Participants allocated to this group remains on the waiting list for occupational therapy, following the natural course of functional improvement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation in Occupational Therapy | Behavioral | Online guidance sessions for post-stroke patients and their caregivers, aimed at improving occupational performance, using standardized scales. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in "Katz Index of Independence in Activities of Daily Living" score indicating greater independence or dependence in performing basic activities of daily living after 2 months. | The Katz Index (Brazilian version) assesses functional status in six activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6. In this specific version, 0 indicates full independence (best outcome) and 6 indicates full dependence (worst outcome). Therefore, lower scores indicate a better outcome. | From enrollment to the end of treatment at 8 weeks |
| Change in "Lawton Instrumental Activities of Daily Living" score indicating greater independence or dependence in performing instrumental activities of daily living after 2 months. | The Lawton Scale (Brazilian version) assesses independent living skills such as using the phone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for their own medications, and ability to handle finances. Scores range from 7 to 21. Higher scores indicate greater independence (better outcome). | From enrollment to the end of treatment at 8 weeks |
| Change in "Motor Activity Log" score for quantitative and qualitative analysis of the use of the affected upper limb. | The MAL (Brazilian version) scale assesses how well the patient uses the affected upper limb. Participants rate the quality of movement on a scale from 0 (The weaker arm is not used) to 5 (Ability to use the weaker arm is just as good as before the stroke). The final score is the mean of the items. Higher scores indicate better movement quality (better outcome). | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Physical Medicine and Rehabilitation of the Hospital das ClÃnicas of the Faculty of Medicine of USP | São Paulo | São Paulo | 04101-300 | Brazil |
There will be no sharing of Individual Participant Data (IPD). This decision is based on Law Nº. 13.709, of August 14, 2018 (General Law on the Protection of Personal Data - LGPD), specifically regarding the protection of sensitive data (Article 5, item II), relating to health and sex life, genetics or biometrics. The disclosure of raw data, even if pseudonymized, may pose risks of re-identification of participants, who are vulnerable patients (post-stroke) treated by the Unified Health System (SUS) at IMREA FMUSP. The publication of results will occur exclusively in an aggregated and statistical manner, preserving medical confidentiality and the identity of volunteers, as recommended by the resolutions of the National Health Council (CNS/CONEP).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2025 | Jan 20, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 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 |