- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389811
Telerehabilitation and Occupational Performance in Stroke
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:
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
São Paulo
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São Paulo, São Paulo, Brazil, 04101-300
- Institute of Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of USP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation
Participants in this group receive Occupational Therapy guidance via telehealth (telerehabilitation) focused on improving occupational performance.
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Online guidance sessions for post-stroke patients and their caregivers, aimed at improving occupational performance, using standardized scales.
|
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No Intervention: Waiting List
Participants allocated to this group remains on the waiting list for occupational therapy, following the natural course of functional improvement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
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.
|
From enrollment to the end of treatment at 8 weeks
|
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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
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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).
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From enrollment to the end of treatment at 8 weeks
|
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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
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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).
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From enrollment to the end of treatment at 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Health Services Administration
- Delivery of Health Care
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Telerehabilitation
- Occupational Therapy
Other Study ID Numbers
- 86185525800000068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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