NCT07389811

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 8, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

Occupational TherapyTelerehabilitationStrokePublic HealthWaiting Lists

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Participants in this group receive Occupational Therapy guidance via telehealth (telerehabilitation) focused on improving occupational performance.

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.

Interventions

Online guidance sessions for post-stroke patients and their caregivers, aimed at improving occupational performance, using standardized scales.

Telerehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of USP

São Paulo, São Paulo, 04101-300, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

TelerehabilitationOccupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2026

First Posted

February 5, 2026

Study Start

July 27, 2025

Primary Completion

December 5, 2025

Study Completion

December 26, 2025

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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).

Locations