Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

NCT ID: NCT04835363

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-11-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group - Patients

Usual care and rehabilitation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

OT intervention group - Patients

Patients assigned to the experimental group are included in an early occupational therapy intervention program.

Group Type: EXPERIMENTAL

Early Occupational Therapy intervention

Intervention Type: OTHER

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.

Control group - Caregivers

Caregivers of patients who receive usual care and rehabilitation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

OT intervention group - Caregivers

Caregivers of the patients that are in the experimental group and are included in an early occupational therapy intervention program.

Group Type: EXPERIMENTAL

Early Occupational Therapy intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Patricia García Perez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PATRICIA GARCIA PEREZ

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39159190 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EOTIHDAS2021

Identifier Type: -

Identifier Source: org_study_id