Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Early Occupational Therapy intervention

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group - Patients; Usual care and rehabilitation.
Experimental: OT intervention group - Patients; Patients assigned to the experimental group 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.
No Intervention: Control group - Caregivers; Caregivers of patients who receive usual care and rehabilitation.
Experimental: OT intervention group - Caregivers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Before intervention (baseline) and after intervention (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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.	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).	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).	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.	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.	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).	Before intervention (baseline) and after intervention (3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Before intervention (baseline) and after intervention (3 months)

Collaborators and Investigators

• Sponsor: University of Malaga
• Investigators: Principal Investigator: PATRICIA GARCIA PEREZ, University of Malaga

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; caregivers; occupational therapy; patient discharge
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: EOTIHDAS2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No