StrokeNCT07389811
Telerehabilitation and Occupational Performance in Stroke
A study testing Telerehabilitation in Occupational Therapy in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telerehabilitation in Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jul 2025to 26 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Clinically stable
- Diagnosis of sequelae of stroke (regardless of modified Rankin scale score)
- On a waiting list with medical indication for Occupational Therapy at IMREA HCFMUSP
- Access to a computer, tablet, or smartphone with internet connection allowing for video calls
- Ability to understand the Portuguese language
- Availability of a caregiver to assist during therapy sessions, if necessary
Who cannot join
- Clinically unstable patients (e.g., frail elderly with decompensated chronic diseases)
- High-risk pregnant women
- Lack of access to internet or devices required for telerehabilitation
- Absence of a caregiver when assistance is required for sessions
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of USP
São Paulo, São Paulo, 04101-300
About this study
Official title: Effects of Telerehabilitation on the Occupational Performance of Stroke Patients Treated by an Occupational Therapy Service: a Randomized Clinical Trial
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:
Read more
- What are the effects of occupational therapy services provided through telerehabilitation for the population with stroke sequelae?
- Do the guidelines provided by telerehabilitation result in improved occupational performance (ability to perform activities of daily living) of the participants?
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:
- Answer a sociodemographic questionnaire;
- Participate in assessments using standardized scales on basic and instrumental activities of daily living and use of the affected limb (Instrumental Activities of Daily Living Scale, Katz Scale, and Motor Activity Log).
- Receive and apply Occupational Therapy guidelines (if in the intervention group).
- Conditions
- Stroke
- Being tested
- Telerehabilitation in Occupational Therapy
- Keywords
- Occupational Therapy, Telerehabilitation, Stroke, Public Health, Waiting Lists
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation in Occupational TherapyBehavioural
Online guidance sessions for post-stroke patients and their caregivers, aimed at improving occupational performance, using standardized scales.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Participants in this group receive Occupational Therapy guidance via telehealth (telerehabilitation) focused on improving occupational performance. Receives: Behavioral: Telerehabilitation in Occupational Therapy |
| Waiting List | No intervention | Participants allocated to this group remains on the waiting list for occupational therapy, following the natural course of functional improvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start27 Jul 2025
- Primary completion5 Dec 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Tadeu Sugawara, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389811
- Sponsor's protocol ID
- 86185525800000068
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telerehabilitation on the Occupational Performance of Stroke Patients Treated by an Occupational Therapy Service: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07389811
- Acronym / sponsor ID
- 86185525800000068
- Conditions
- Stroke
- Keywords
- Occupational Therapy, Telerehabilitation, Stroke, Public Health, Waiting Lists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 5 Feb 2026 (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 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:
- What are the effects of occupational therapy services provided through telerehabilitation for the population with stroke sequelae?
- Do the guidelines provided by telerehabilitation result in improved occupational performance (ability to perform activities of daily living) of the participants?
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:
- Answer a sociodemographic questionnaire;
- Participate in assessments using standardized scales on basic and instrumental activities of daily living and use of the affected limb (Instrumental Activities of Daily Living Scale, Katz Scale, and Motor Activity Log).
- Receive and apply Occupational Therapy guidelines (if in the intervention group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: Telerehabilitation in Occupational TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable
- Diagnosis of sequelae of stroke (regardless of modified Rankin scale score)
- On a waiting list with medical indication for Occupational Therapy at IMREA HCFMUSP
- Access to a computer, tablet, or smartphone with internet connection allowing for video calls
- Ability to understand the Portuguese language
Key exclusion criteria (4 listed)
- Clinically unstable patients (e.g., frail elderly with decompensated chronic diseases)
- High-risk pregnant women
- Lack of access to internet or devices required for telerehabilitation
- Absence of a caregiver when assistance is required for sessions
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 |
|---|---|---|
| Telerehabilitation in Occupational TherapyOnline guidance sessions for post-stroke patients and their caregivers, aimed at improving occupational performance, using standardized scales. | Behavioural | Telerehabilitation |
Primary outcome
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Change in "Lawton Instrumental Activities of Daily Living" score indicating greater independence or dependence in performing instrumental activities of daily living after 2 months.
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Change in "Motor Activity Log" score for quantitative and qualitative analysis of the use of the affected upper limb.
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. 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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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in Occupational Therapy in people with Stroke, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. 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 5 Feb 2026.