Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

Stroke Clinical Trial

Official title:

Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835363
• Other study ID #: EOTIHDAS2021
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general objective of this study is to determine if an early occupational therapy intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the 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 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 to the caregiver about specific care and neurorehabilitation.

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 intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the 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 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 to the caregiver about specific care and neurorehabilitation. Primary outcome: functional independence of the patient and support needs in activities of daily living. Secondary outcomes: improvement in sensory-motor skills, perceptual-cognitive skills, communication skills, quality of life and levels of anxiety and depression of the patient, as well as caregiver coping strategies and burden. The final results are evaluated three months after discharge. At the same time, data are collected on readmissions to the hospital, mortality, return to work and return to driving, as well as an economic health analysis. Interviews and evaluations will be conducted with all patients and caregivers before discharge and three months after. 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 Málaga Oeste (Spain), being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department. Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 45-100 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 <45.
• 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.
• Does not understand Spanish or English.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• 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 the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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).	3 months
Secondary	Patient's sensory-motor skills	Assessed with Fugl-Meyer sensory motor assessment (FMA). It evaluates the upper limb (maximum score of 66 corresponding to normal motor function) and lower extremity (maximum score of 34). Unit of measure will be the result of this assessment. It has four categories with different scores: total motor skills of the upper limb (from 0 to 66, higher score, better outcome), sensitivity (0 to 12, higher score, better outcome), passive joint movement (0 to 24, higher score, better outcome) and joints pain (0 to 24, higher score, better outcome).	3 months
Secondary	Caregiver coping strategies	Assessed with Inventory of coping strategies (CSI). As it describes, the main purpose of this scale is to find the type of situations that cause problems for people in their daily lives and how they deal with these problems. Unit of measure will be the result of this assessment. It has different categories and the final score is deducted using correction keys and a scale. In general, higher score means better outcome.	3 months
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. The MoCA includes sections on visuospatial / executive functions, nomenclature, attention, language, abstraction, memory, and orientation. Unit of measure will be the result of this assessment.The final score goes from 0 to 30 (higher score, better outcome).	3 months
Secondary	Patient communication skills	Assessed wit 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).	3 months
Secondary	Stroke and Aphasia Quality of life scale, evaluating physical skills, psychosocial skills, communication and energy	Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). The SAQOL-39 was derived from the Stroke Specific Quality of Life Scale and four additional items specifically targeting aphasia patients, spanning four domains: physical, psychosocial, communication, and energy. Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome).	3 months
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).	3 months
Secondary	Caregiver burden	Assessed with Caregiver Burden Scale (CBS). The CBS is a questionnaire with 22 questions (answered in writing by the caregiver) on the burden of health aspects of the caregiver, the feeling of psychological well-being, relationships, the social network, physical workload and environmental aspects they can be important. Unit of measure will be the result of this assessment. Final score goes from 0 to 88 (lower score, better outcome).	3 months
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.	3 months
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).	3 months
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).	3 months