StrokeNCT04835363
Early Occupational Therapy Intervention in the Hospital Discharge After Stroke
A study testing Early Occupational Therapy intervention in people with Stroke, run by University of Malaga at 1 site in Spain.
Trial summary
The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life and functional independence of the patient, compared with the control group that will have the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Early Occupational Therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of stroke with single or multiple vascular lesions that have occurred in the same time period, demonstrated by neuroimaging tests (CT or MRI).
- 18 years of age or older.
- Patient must live a maximum of 30 minutes away from the hospital center.
- Must present > 2 or <26 points on the National Institute of Health scale (NIHSS) and 30-100 points on the Barthel Index (BI) on the second day of the stroke (with BI 100, the patient can be included if the Montreal Cognitive Assessment is <26).
- Patient must present some motor deficit that makes it difficult to carry out his ADL.
- Inclusion in the study occurs prior to hospital discharge.
Who cannot join
- NIHSS> 26 and BI <30.
- Life expectancy <1 year.
- Previous stroke, dementia or other types of illnesses associated with dementia and other neurological, psychiatric or medical illnesses (for example, severe epilepsy, head trauma, schizophrenia, COPD, severe or unstable heart disease, sleep apnea) that could alter cognitive function.
- Moderate-severe aphasia.
- Does not understand Spanish or English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial
The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life and functional independence of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation.
Read the detailed description
Background: Stroke is the leading cause of acquired disability in adults, being a cerebrovascular disease of great impact in health and social terms, due not only to its prevalence and incidence, but to the great repercussion in terms of dependence and its consequent impact on the life of the patient and family.
General and specific objectives: The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge about specific care and neurorehabilitation. Primary outcome: quality of life and functional independence. Secondary outcomes: improvement in sensory-motor skills, perceptual-cognitive skills, communication skills, levels of anxiety and depression of the patient, as well as caregivers' burden and coping strategies. The final results are evaluated three months after discharge.
Study Design: This is a prospective, randomized, controlled clinical trial. The sample size is made up of 60 patients who will be divided into two groups: the control group, with 30 users, and the experimental group, with another 30 users. The sample will be made up of patients who have suffered a stroke and have been discharged from the neurology service of a second-level hospital in West Malaga (Spain), being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department. Patients assigned to the experimental group and their caregivers are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation.
- Conditions
- Stroke
- Being tested
- Early Occupational Therapy intervention
- Keywords
- patient discharge, occupational therapy, rehabilitation, caregivers
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Occupational Therapy interventionOther
four-week OT intervention program for patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge about specific care and neurorehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Control group - Patients | No intervention | Usual care and rehabilitation. |
| OT intervention group - Patients | Experimental | Patients assigned to the experimental group are included in an early occupational therapy intervention program. Receives: Other: Early Occupational Therapy intervention |
| Control group - Caregivers | No intervention | Caregivers of patients who receive usual care and rehabilitation. |
| OT intervention group - Caregivers | Experimental | Caregivers of the patients that are in the experimental group and are included in an early occupational therapy intervention program. Receives: Other: Early Occupational Therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Quality of Life
Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Secondary outcomes (10)
Patient's Sensory-motor Skills
Assessed with Fugl Meyer Assessment (FMA). Unit of measure will be the result of this assessment. Total score is 0 to 126 (the higher score, the better upper limb sensory-motor skills).
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Perceptual-cognitive Skills
Assessed with Montreal Cognitive Assessment (MoCA). MoCA has been proposed as a screening tool that promises good sensitivity to deficits that result from stroke and vascular cognitive impairment. Unit of measure will be the result of this assessment.The final score goes from 0 to 30 (higher score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Communication Skills
Assessed with Communicative Activity Log (CAL). Scale that allows obtaining information on communication skills in activities of daily life referring to comprehensive and expressive aspects of language. Unit of measure will be the result of this assessment. Final score goes from 0 to 190 (higher score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Depression of the Patient
Assessed with Beck Depression Inventory (BDI-2). It is one of the most commonly used instruments to measure the severity of depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 63 (lower score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Mobility
Assessed with Time up and go (TUG). The TUG assesses basic mobility, timing the time required for a person to get up from a standardized chair, walk a distance of three meters, turn, return to the chair, and sit down again. Unit of measure will be the result of this assessment, which is the time in seconds. Shorter time means better performance.
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Functional Balance
Assessed with Berg Balance Scale (BBS) which evaluates assesses functional balance. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (higher score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Anxiety of the Patient
Assessed with Hamilton anxiety scale. This scale assesses the severity of anxiety globally in patients who meet criteria for anxiety or depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (lower score, better outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Functional Independence Assessed With Barthel Index
The main unit of measure is the result of Barthel Index (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome. The main goal of this research is to assess independence of the patient and support needs in activities of daily living. The Barthel index measures the extent to which someone can function independently during basic activities of daily living.
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Functional Independence Assessed With Stroke Impact Scale-16
Unit of measure will be the result of this assessment. The score goes from 16 to 80, 80 meaning independence (higher score, better outcome). The usefulness of this scale is similar to that of the Barthel Index, although it is more sensitive than the latter to discriminate between patients with mild disabilities.
Measured: Before intervention (baseline) and after intervention (3 months)
Patient Disability Assessed With Modified Rankin Scale (mRs)
The mRS is used to describe disability in general. Unit of measure will be the result of this assessment. The score goes from 0 to 6, 0 meaning no symptoms and 6 meaning death (higher score, worse outcome).
Measured: Before intervention (baseline) and after intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia García Perez, University of Malaga
- Investigators
- PATRICIA GARCIA PEREZ, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835363
- Sponsor's protocol ID
- EOTIHDAS2021
- Status last verified
- Feb 2025
- First submitted
- 25 Mar 2021
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Perez P, Rodriguez-Martinez MC, Gallardo-Tur A, Blanco-Reina E, de la Cruz-Cosme C, Lara JP. Early Occupational Therapy Intervention post-stroke (EOTIPS): A randomized controlled trial. PLoS One. 2024 Aug 19;19(8):e0308800. doi: 10.1371/journal.pone.0308800. eCollection 2024.
PubMed 39159190
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04835363
- Acronym / sponsor ID
- EOTIHDAS2021
- Conditions
- Stroke
- Keywords
- patient discharge, occupational therapy, rehabilitation, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life and functional independence of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation.
Detailed description
Background: Stroke is the leading cause of acquired disability in adults, being a cerebrovascular disease of great impact in health and social terms, due not only to its prevalence and incidence, but to the great repercussion in terms of dependence and its consequent impact on the life of the patient and family.
General and specific objectives: The general objective of this study is to determine if an early occupational therapy (OT) intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the quality of life of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge about specific care and neurorehabilitation. Primary outcome: quality of life and functional independence. Secondary outcomes: improvement in sensory-motor skills, perceptual-cognitive skills, communication skills, levels of anxiety and depression of the patient, as well as caregivers' burden and coping strategies. The final results are evaluated three months after discharge.
Study Design: This is a prospective, randomized, controlled clinical trial. The sample size is made up of 60 patients who will be divided into two groups: the control group, with 30 users, and the experimental group, with another 30 users. The sample will be made up of patients who have suffered a stroke and have been discharged from the neurology service of a second-level hospital in West Malaga (Spain), being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department. Patients assigned to the experimental group and their caregivers are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group - Patients | No intervention | –Usual care and rehabilitation. |
| OT intervention group - Patients | Experimental | Other: Early Occupational Therapy interventionPatients assigned to the experimental group are included in an early occupational therapy intervention program. |
| Control group - Caregivers | No intervention | –Caregivers of patients who receive usual care and rehabilitation. |
| OT intervention group - Caregivers | Experimental | Other: Early Occupational Therapy interventionCaregivers of the patients that are in the experimental group and are included in an early occupational therapy intervention program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of stroke with single or multiple vascular lesions that have occurred in the same time period, demonstrated by neuroimaging tests (CT or MRI).
- 18 years of age or older.
- Patient must live a maximum of 30 minutes away from the hospital center.
- Must present > 2 or <26 points on the National Institute of Health scale (NIHSS) and 30-100 points on the Barthel Index (BI) on the second day of the stroke (with BI 100, the patient can be included if the Montreal Cognitive Assessment is <26).
- Patient must present some motor deficit that makes it difficult to carry out his ADL.
Key exclusion criteria (5 listed)
- NIHSS> 26 and BI <30.
- Life expectancy <1 year.
- Previous stroke, dementia or other types of illnesses associated with dementia and other neurological, psychiatric or medical illnesses (for example, severe epilepsy, head trauma, schizophrenia, COPD, severe or unstable heart disease, sleep apnea) that could alter cognitive function.
- Moderate-severe aphasia.
- Does not understand Spanish or English.
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 |
|---|---|---|
| Early Occupational Therapy interventionfour-week OT intervention program for patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge about specific care and neurorehabilitation. | Other | OT intervention group - Caregivers, OT intervention group - Patients |
Primary outcome
Patient Quality of Life
Time frame: Before intervention (baseline) and after intervention (3 months)
Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome).
10 secondary outcomes
Patient's Sensory-motor Skills
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Perceptual-cognitive Skills
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Communication Skills
Time frame: Before intervention (baseline) and after intervention (3 months)
Depression of the Patient
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Mobility
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Functional Balance
Time frame: Before intervention (baseline) and after intervention (3 months)
Anxiety of the Patient
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Functional Independence Assessed With Barthel Index
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Functional Independence Assessed With Stroke Impact Scale-16
Time frame: Before intervention (baseline) and after intervention (3 months)
Patient Disability Assessed With Modified Rankin Scale (mRs)
Time frame: Before intervention (baseline) and after intervention (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39159190Garcia-Perez P, Rodriguez-Martinez MC, Gallardo-Tur A, Blanco-Reina E, de la Cruz-Cosme C, Lara JP. Early Occupational Therapy Intervention post-stroke (EOTIPS): A randomized controlled trial. PLoS One. 2024 Aug 19;19(8):e0308800. doi: 10.1371/journal.pone.0308800. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
PATRICIA GARCIA PEREZ principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Occupational Therapy intervention in people with Stroke, run by University of Malaga at 1 site in Spain.
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 5 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 10 Feb 2025. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Quality of Life (time frame: Before intervention (baseline) and after intervention (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835363, which also lists 1 linked publication.
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 10 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.