Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

Not Applicable

Completed

Conditions: Stroke

Interventions: Other: Early Occupational Therapy intervention

Registration Number: NCT04835363

Lead Sponsor: University of Malaga

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 117

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OT intervention.	Early Occupational Therapy intervention	Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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 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.
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.
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).