Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

NCT04835363 | Completed Results

• 1 other identifier: EOTIHDAS2021
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

patient discharge; occupational therapy; rehabilitation; caregivers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patient's Sensory-motor Skills

  Before intervention (baseline) and after intervention (3 months)

• Patient Perceptual-cognitive Skills

  Before intervention (baseline) and after intervention (3 months)

• Patient Communication Skills

  Before intervention (baseline) and after intervention (3 months)

• Depression of the Patient

  Before intervention (baseline) and after intervention (3 months)

• Patient Mobility

  Before intervention (baseline) and after intervention (3 months)

Other Outcomes (2)

• Caregiver Burden.

  Before intervention (baseline) and after intervention (3 months)

• Caregivers Coping Strategies.

  Before intervention (baseline) and after intervention (3 months)

Study Arms (4)

Control group - Patients

NO INTERVENTION

Usual care and rehabilitation.

OT intervention group - Patients

EXPERIMENTAL

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

Other: Early Occupational Therapy intervention

Control group - Caregivers

NO INTERVENTION

Caregivers of patients who receive usual care and rehabilitation.

OT intervention group - Caregivers

EXPERIMENTAL

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

Interventions

Early Occupational Therapy intervention 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.

OT intervention group - Caregivers; OT intervention group - Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Related Publications (1)

• 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.

  PMID: 39159190 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Garcia-perez, Patricia
• Organization: University of Malaga

terapiaocupacional.patricia@gmail.com

+34 675447206

Study Officials

• PATRICIA GARCIA PEREZ

  University of Malaga

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)