Stroke
Conditions
Keywords
patient discharge, occupational therapy, rehabilitation, caregivers
Brief 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 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.
Interventions
OTHEREarly 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.
Sponsors
University of Malaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety of the Patient | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient's Sensory-motor Skills | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient Perceptual-cognitive Skills | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient Communication Skills | Before intervention (baseline) and after intervention (3 months) | 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). |
| Depression of the Patient | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient Functional Independence Assessed With Stroke Impact Scale-16 | Before intervention (baseline) and after intervention (3 months) | 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. |
| Patient Disability Assessed With Modified Rankin Scale (mRs) | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient Mobility | Before intervention (baseline) and after intervention (3 months) | 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. |
| Patient Functional Balance | Before intervention (baseline) and after intervention (3 months) | 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). |
| Patient Functional Independence Assessed With Barthel Index | Before intervention (baseline) and after intervention (3 months) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden. | Before intervention (baseline) and after intervention (3 months) | 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. |
| Caregivers Coping Strategies. | Before intervention (baseline) and after intervention (3 months) | 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. |
Countries
Spain
Participant flow
Pre-assignment details
Out of all the patients that were asked for enrollment, only 55 had a relative or friend as a caregiver and agreed to cooperate with the research.
Participants by arm
| Arm | Count |
|---|---|
| Control Group - Patients Usual care provided by hospital/community staff. | 31 |
| EOTIPS (OT Intervention) - Patients Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program.
Early Occupational Therapy intervention: four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. | 31 |
| Control Group - Caregivers Caregivers of patients who received usual care by ward and rehabilitation staff. | 27 |
| EOTIPS (OT Intervention) - Caregivers Caregivers of patients assigned to the experimental group who are included in an early occupational therapy intervention program.
Early Occupational Therapy intervention (EOTIPS): four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving patient quality of life and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. | 28 |
| Total | 117 |
Baseline characteristics
| Characteristic | Control Group - Patients | EOTIPS (OT Intervention) - Patients | Control Group - Caregivers | EOTIPS (OT Intervention) - Caregivers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 13 Participants | 3 Participants | 5 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 24 Participants | 23 Participants | 81 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10.6 | 68.5 years STANDARD_DEVIATION 10.7 | 60 years STANDARD_DEVIATION 22.3 | 61.2 years STANDARD_DEVIATION 19.8 | 67.5 years STANDARD_DEVIATION 10.6 |
| Education High school | 5 Participants | 3 Participants | — | — | 8 Participants |
| Education No studies | 1 Participants | 1 Participants | — | — | 2 Participants |
| Education Primary school | 15 Participants | 9 Participants | — | — | 24 Participants |
| Education Reads/writes | 8 Participants | 12 Participants | — | — | 20 Participants |
| Education University | 2 Participants | 6 Participants | — | — | 8 Participants |
| Employment status Househusband/housewife | 1 Participants | 4 Participants | — | — | 5 Participants |
| Employment status Other activities | 0 Participants | 1 Participants | — | — | 1 Participants |
| Employment status Retired | 20 Participants | 18 Participants | — | — | 38 Participants |
| Employment status Temporary disability | 8 Participants | 7 Participants | — | — | 15 Participants |
| Employment status Unemployed | 2 Participants | 1 Participants | — | — | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 25 Participants | 25 Participants | 23 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 2 Participants | 5 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital status Divorced | 2 Participants | 2 Participants | — | — | 4 Participants |
| Marital status Married/living with partner | 21 Participants | 20 Participants | — | — | 41 Participants |
| Marital status Single | 2 Participants | 3 Participants | — | — | 5 Participants |
| Marital status Widowed | 6 Participants | 6 Participants | — | — | 12 Participants |
| Native language: spanish | 29 Participants | 29 Participants | 26 Participants | 26 Participants | 110 Participants |
| Region of Enrollment Spain | 31 participants | 31 participants | 27 participants | 28 participants | 117 participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 15 Participants | 20 Participants | 62 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 12 Participants | 8 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 31 | 1 / 31 | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 27 | 0 / 28 |
Outcome results
Primary
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)
Population: Patients that enrolled EOTIPS program were assessed with SAQOL-39 in order to define wether their quality of life has improved, comparing to a control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Quality of Life | After intervention (3 months) | 3.41 score on a scale | Standard Deviation 0.69 |
| Control Group | Patient Quality of Life | Before intervention (baseline) | 2.51 score on a scale | Standard Deviation 0.75 |
| OT Intervention. | Patient Quality of Life | After intervention (3 months) | 3.91 score on a scale | Standard Deviation 0.7 |
| OT Intervention. | Patient Quality of Life | Before intervention (baseline) | 2.67 score on a scale | Standard Deviation 0.72 |
p-value: 0.029ANOVA
Secondary
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)
Population: Anxiety of the patient was assessed with Hamilton anxiety scale to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Anxiety of the Patient | After intervention (3 months). | 11.3 score on a scale | Standard Deviation 9.4 |
| Control Group | Anxiety of the Patient | Before intervention (baseline). | 11.50 score on a scale | Standard Deviation 10.88 |
| OT Intervention. | Anxiety of the Patient | After intervention (3 months). | 5.5 score on a scale | Standard Deviation 7.94 |
| OT Intervention. | Anxiety of the Patient | Before intervention (baseline). | 8.47 score on a scale | Standard Deviation 10.96 |
p-value: 0.055ANOVA
Secondary
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)
Population: Depression was assessed with Beck Depression Inventory (BDI-2) to define if the level of depression was lower in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Depression of the Patient | After intervention (3 months). | 15.3 score on a scale | Standard Deviation 10.48 |
| Control Group | Depression of the Patient | Before intervention (baseline). | 13.60 score on a scale | Standard Deviation 9.76 |
| OT Intervention. | Depression of the Patient | After intervention (3 months). | 8.4 score on a scale | Standard Deviation 8.88 |
| OT Intervention. | Depression of the Patient | Before intervention (baseline). | 11.23 score on a scale | Standard Deviation 9.11 |
p-value: 0.011ANOVA
Secondary
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)
Population: Communication was assessed with Communicative Activity Log (CAL) to define if the communication skills were better in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Communication Skills | After intervention (3 months). | 116 Score on a scale | Standard Deviation 31.1 |
| Control Group | Patient Communication Skills | Before intervention (baseline). | 109.00 Score on a scale | Standard Deviation 37 |
| OT Intervention. | Patient Communication Skills | After intervention (3 months). | 137 Score on a scale | Standard Deviation 24.2 |
| OT Intervention. | Patient Communication Skills | Before intervention (baseline). | 122.00 Score on a scale | Standard Deviation 27.3 |
p-value: 0.078ANOVA
Secondary
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)
Population: The patient general disability was assessed with modified Rankin scale to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Disability Assessed With Modified Rankin Scale (mRs) | After intervention (3 months). | 2.5 Score on a scale | Standard Deviation 1.04 |
| Control Group | Patient Disability Assessed With Modified Rankin Scale (mRs) | Before intervention (baseline). | 3.60 Score on a scale | Standard Deviation 0.77 |
| OT Intervention. | Patient Disability Assessed With Modified Rankin Scale (mRs) | After intervention (3 months). | 1.83 Score on a scale | Standard Deviation 1.05 |
| OT Intervention. | Patient Disability Assessed With Modified Rankin Scale (mRs) | Before intervention (baseline). | 3.63 Score on a scale | Standard Deviation 0.8 |
p-value: 0.004ANOVA
Secondary
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)
Population: Functional balance was assessed with Berg Balance Scale (BBS) to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Functional Balance | After intervention (3 months). | 45.3 score on a scale | Standard Deviation 11.7 |
| Control Group | Patient Functional Balance | Before intervention (baseline). | 22.70 score on a scale | Standard Deviation 17.9 |
| OT Intervention. | Patient Functional Balance | After intervention (3 months). | 47 score on a scale | Standard Deviation 11.1 |
| OT Intervention. | Patient Functional Balance | Before intervention (baseline). | 27.60 score on a scale | Standard Deviation 14.6 |
p-value: 0.358ANOVA
Secondary
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)
Population: The functional independence was assessed with Barthel Index to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Functional Independence Assessed With Barthel Index | After intervention (3 months). | 85 score on a scale | Standard Error 16.7 |
| Control Group | Patient Functional Independence Assessed With Barthel Index | Before intervention (baseline). | 52.5 score on a scale | Standard Error 21 |
| OT Intervention. | Patient Functional Independence Assessed With Barthel Index | After intervention (3 months). | 90 score on a scale | Standard Error 14.9 |
| OT Intervention. | Patient Functional Independence Assessed With Barthel Index | Before intervention (baseline). | 54.7 score on a scale | Standard Error 20.5 |
p-value: 0.496ANOVA
Secondary
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)
Population: The functional independence was assessed with SIS-16 to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Functional Independence Assessed With Stroke Impact Scale-16 | After intervention (3 months). | 61.9 score on a scale | Standard Deviation 12.6 |
| Control Group | Patient Functional Independence Assessed With Stroke Impact Scale-16 | Before intervention (baseline). | 36.60 score on a scale | Standard Deviation 14 |
| OT Intervention. | Patient Functional Independence Assessed With Stroke Impact Scale-16 | After intervention (3 months). | 66.3 score on a scale | Standard Deviation 10.7 |
| OT Intervention. | Patient Functional Independence Assessed With Stroke Impact Scale-16 | Before intervention (baseline). | 37.70 score on a scale | Standard Deviation 11 |
p-value: 0.241ANOVA
Secondary
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)
Population: Basic mobility was assessed with Timed Up and Go (TUG)) to define if it improved more in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Mobility | After intervention (3 months). | 12.4 seconds | Standard Deviation 4.83 |
| Control Group | Patient Mobility | Before intervention (baseline). | 28.40 seconds | Standard Deviation 17.68 |
| OT Intervention. | Patient Mobility | After intervention (3 months). | 14.3 seconds | Standard Deviation 12.8 |
| OT Intervention. | Patient Mobility | Before intervention (baseline). | 29.00 seconds | Standard Deviation 12.9 |
p-value: 0.797ANOVA
Secondary
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)
Population: Cognitive impairment was assessed with Montreal Cognitive Assessment (MoCA) to define if cognition has improved in the EOTIPS group compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient Perceptual-cognitive Skills | After intervention (3 months). | 20.1 Score on a scale | Standard Deviation 7.06 |
| Control Group | Patient Perceptual-cognitive Skills | Before intervention (baseline). | 16.6 Score on a scale | Standard Deviation 7.33 |
| OT Intervention. | Patient Perceptual-cognitive Skills | After intervention (3 months). | 24.8 Score on a scale | Standard Deviation 6.58 |
| OT Intervention. | Patient Perceptual-cognitive Skills | Before intervention (baseline). | 18.6 Score on a scale | Standard Deviation 7.16 |
p-value: 0.012ANOVA
Secondary
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)
Population: All participants were assessed with Fugl-Meyer sensory motor assessment (FMA) in order to define wether EOTIPS program induced an improvement in the motor upper limb functions compared to the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Patient's Sensory-motor Skills | After intervention (3 months) | 111.10 Score on a scale | Standard Deviation 17.6 |
| Control Group | Patient's Sensory-motor Skills | Before intervention (baseline). | 99.80 Score on a scale | Standard Deviation 22.6 |
| OT Intervention. | Patient's Sensory-motor Skills | After intervention (3 months) | 117 Score on a scale | Standard Deviation 12.6 |
| OT Intervention. | Patient's Sensory-motor Skills | Before intervention (baseline). | 102.00 Score on a scale | Standard Deviation 18.9 |
p-value: 0.148ANOVA
Other Pre-specified
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)
Population: The caregivers that wanted to participate in the study were evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Caregiver Burden. | After intervention (3 months). | 3.91 Score on a scale | Standard Deviation 0.7 |
| Control Group | Caregiver Burden. | Before intervention (baseline). | 12.8 Score on a scale | Standard Deviation 12.6 |
| OT Intervention. | Caregiver Burden. | Before intervention (baseline). | 14.5 Score on a scale | Standard Deviation 6.91 |
| OT Intervention. | Caregiver Burden. | After intervention (3 months). | 3.41 Score on a scale | Standard Deviation 0.69 |
p-value: 0.019ANOVA
Other Pre-specified
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)
Population: The caregivers that were involved in the recovery of the patients were included in the study and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Caregivers Coping Strategies. | Engagement strategies - BEFORE | 38.2 Score on a scale | Standard Deviation 12.6 |
| Control Group | Caregivers Coping Strategies. | Disengagement strategies - BEFORE | 33.9 Score on a scale | Standard Deviation 6.8 |
| Control Group | Caregivers Coping Strategies. | Engagement strategies - AFTER | 40.8 Score on a scale | Standard Deviation 13.6 |
| Control Group | Caregivers Coping Strategies. | Disengagement strategies - AFTER | 37.4 Score on a scale | Standard Deviation 7.95 |
| OT Intervention. | Caregivers Coping Strategies. | Disengagement strategies - AFTER | 38.0 Score on a scale | Standard Deviation 7.6 |
| OT Intervention. | Caregivers Coping Strategies. | Engagement strategies - BEFORE | 42.5 Score on a scale | Standard Deviation 10.2 |
| OT Intervention. | Caregivers Coping Strategies. | Engagement strategies - AFTER | 49.0 Score on a scale | Standard Deviation 10.5 |
| OT Intervention. | Caregivers Coping Strategies. | Disengagement strategies - BEFORE | 36.4 Score on a scale | Standard Deviation 8.18 |
Comparison: ENGAGEMENT STRATEGIESp-value: 0.141ANOVA
Comparison: DISENGAGEMENT STRATEGIESp-value: 0.496ANOVA