An interventional study of Early Occupational Therapy intervention in Stroke, sponsored by University of Malaga. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 117 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Usual care and rehabilitation.
Patients assigned to the experimental group are included in an early occupational therapy intervention program.
Other: Early Occupational Therapy intervention
Caregivers of patients who receive usual care and rehabilitation.
Caregivers of the patients that are in the experimental group and are included in an early occupational therapy intervention program.
Other: Early Occupational Therapy intervention
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.
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).
Time frame: Before intervention (baseline) and after intervention (3 months)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Before intervention (baseline) and after intervention (3 months)
Caregiver Burden.
Caregiver burden was evaluated with Caregiver Burden Scale (CBS). The Caregiver Burden Scale (CBS) is a 22-item scale that assesses the burden subjectively experienced by caregivers.The total score range is 0 to 88, where the higher the score, the more severe the burden: 0-21 no or mild burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and ≥61 severe burden.
Time frame: Before intervention (baseline) and after intervention (3 months)
Caregivers Coping Strategies.
The caregivers coping strategies were evaluated with the Coping Strategies Inventory (CSI), that was adapted to 40 items. The scale measures individual coping strategies that are broadly classified into two basic approaches to managing stressful situations: coping activities that involve the individual in the stressful situation (engagement strategies) and coping activities that disengage the individual (disengagement strategies). Total subscales score range are: disengagement strategies 0 to 60 and engagement strategies 0 to 60. The higher the score, the more strategies of that type they have.
Time frame: Before intervention (baseline) and after intervention (3 months)
| Milestone | Patients Control Group | Patients Experimental Group: EOTIPS Intervention. | Caregivers Control Group | Caregivers Experimental Group |
|---|---|---|---|---|
| Started | 31 | 31 | 27 | 28 |
| Completed | 30 | 30 | 27 | 28 |
| Not completed | 1 | 1 | 0 | 0 |
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).
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months) | 3.41 ± 0.69 | 3.91 ± 0.70 |
| Before intervention (baseline) | 2.51 ± 0.75 | 2.67 ± 0.72 |
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).
| Score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months) | 111.10 ± 17.6 | 117 ± 12.6 |
| Before intervention (baseline). | 99.80 ± 22.60 | 102.00 ± 18.90 |
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).
| Score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 20.1 ± 7.06 | 24.8 ± 6.58 |
| Before intervention (baseline). | 16.6 ± 7.33 | 18.6 ± 7.16 |
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).
| Score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 116 ± 31.1 | 137 ± 24.2 |
| Before intervention (baseline). | 109.00 ± 37.00 | 122.00 ± 27.30 |
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).
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 15.3 ± 10.48 | 8.4 ± 8.88 |
| Before intervention (baseline). | 13.60 ± 9.76 | 11.23 ± 9.11 |
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.
| seconds | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 12.4 ± 4.83 | 14.3 ± 12.8 |
| Before intervention (baseline). | 28.40 ± 17.68 | 29.00 ± 12.90 |
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).
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 45.3 ± 11.7 | 47 ± 11.1 |
| Before intervention (baseline). | 22.70 ± 17.90 | 27.60 ± 14.60 |
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).
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 11.3 ± 9.4 | 5.5 ± 7.94 |
| Before intervention (baseline). | 11.50 ± 10.88 | 8.47 ± 10.96 |
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.
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 85 ± 16.7 | 90 ± 14.9 |
| Before intervention (baseline). | 52.5 ± 21 | 54.7 ± 20.5 |
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.
| score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 61.9 ± 12.6 | 66.3 ± 10.7 |
| Before intervention (baseline). | 36.60 ± 14.00 | 37.70 ± 11.00 |
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).
| Score on a scale | Control Group | OT Intervention. |
|---|---|---|
| After intervention (3 months). | 2.5 ± 1.04 | 1.83 ± 1.05 |
| Before intervention (baseline). | 3.60 ± 0.77 | 3.63 ± 0.80 |
Caregiver burden was evaluated with Caregiver Burden Scale (CBS). The Caregiver Burden Scale (CBS) is a 22-item scale that assesses the burden subjectively experienced by caregivers.The total score range is 0 to 88, where the higher the score, the more severe the burden: 0-21 no or mild burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and ≥61 severe burden.
| Score on a scale | Control Group - Caregivers | OT Intervention Group - Caregivers |
|---|---|---|
| After intervention (3 months). | 3.91 ± 0.70 | 3.41 ± 0.69 |
| Before intervention (baseline). | 12.8 ± 12.6 | 14.5 ± 6.91 |
The caregivers coping strategies were evaluated with the Coping Strategies Inventory (CSI), that was adapted to 40 items. The scale measures individual coping strategies that are broadly classified into two basic approaches to managing stressful situations: coping activities that involve the individual in the stressful situation (engagement strategies) and coping activities that disengage the individual (disengagement strategies). Total subscales score range are: disengagement strategies 0 to 60 and engagement strategies 0 to 60. The higher the score, the more strategies of that type they have.
| Score on a scale | Control Group - Caregivers | OT Intervention Group - Caregivers |
|---|---|---|
| Engagement strategies - BEFORE | 38.2 ± 12.6 | 42.5 ± 10.2 |
| Disengagement strategies - BEFORE | 33.9 ± 6.8 | 36.4 ± 8.18 |
| Engagement strategies - AFTER | 40.8 ± 13.6 | 49.0 ± 10.5 |
| Disengagement strategies - AFTER | 37.4 ± 7.95 | 38.0 ± 7.6 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group - Patients | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) |
| OT Intervention (EOTIPS) - Patients | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) |
| Control Group - Caregivers | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| OT Intervention (EOTIPS) - Caregivers | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
The sample size "n" was calculated to represent the total population of patients who suffer a stroke and are admitted to the Virgen de la Victoria University Hospital in Malaga, and who, after the neurological intervention, are left with sequelae susceptible to rehabilitation, but who do not acquire a place as inmates in the rehabilitation unit (a total of 800 stroke admissions to the Hospital are estimated per year).
| Age, Categorical(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 18 | 24 | 23 | 81 |
| >=65 years | 15 | 13 | 3 | 5 | 36 |
| Age, Continuous(years) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Mean | 66.6 ± 10.6 | 68.5 ± 10.7 | 60 ± 22.3 | 61.2 ± 19.8 | 67.5 ± 10.6 |
| Sex: Female, Male(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Female | 15 | 12 | 15 | 20 | 62 |
| Male | 16 | 19 | 12 | 8 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 28 | 25 | 25 | 23 | 101 |
| Not Hispanic or Latino | 3 | 6 | 2 | 5 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Spain | 31 | 31 | 27 | 28 | 117 |
| Native language: spanish(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Count of participants | 29 | 29 | 26 | 26 | 110 |
| Marital status(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Single | 2 | 3 | — | — | 5 |
| Divorced | 2 | 2 | — | — | 4 |
| Widowed | 6 | 6 | — | — | 12 |
| Married/living with partner | 21 | 20 | — | — | 41 |
| Education(Participants) | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| No studies | 1 | 1 | — | — | 2 |
| Reads/writes | 8 | 12 | — | — | 20 |
| Primary school | 15 | 9 | — | — | 24 |
| High school | 5 | 3 | — | — | 8 |
| University | 2 | 6 | — | — | 8 |
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University of Malaga