N/A
N=117
Early Occupational Therapy Intervention in the Hospital Discharge After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04835363 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Patient Quality of Life — 3.41; 3.91; 2.51; 2.67 score on a scale — p=0.029
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early Occupational Therapy intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Malaga
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Quality of Life |
3.41; 3.91; 2.51; 2.67 | 0.029 sig |
| SECONDARY Patient's Sensory-motor Skills |
111.10; 117; 99.80; 102.00 | 0.148 |
| SECONDARY Patient Perceptual-cognitive Skills |
20.1; 24.8; 16.6; 18.6 | 0.012 sig |
| SECONDARY Patient Communication Skills |
116; 137; 109.00; 122.00 | 0.078 |
| SECONDARY Depression of the Patient |
15.3; 8.4; 13.60; 11.23 | 0.011 sig |
| SECONDARY Patient Mobility |
12.4; 14.3; 28.40; 29.00 | 0.797 |
| SECONDARY Patient Functional Balance |
45.3; 47; 22.70; 27.60 | 0.358 |
| SECONDARY Anxiety of the Patient |
11.3; 5.5; 11.50; 8.47 | 0.055 |
| SECONDARY Patient Functional Independence Assessed With Barthel Index |
85; 90; 52.5; 54.7 | 0.496 |
| SECONDARY Patient Functional Independence Assessed With Stroke Impact Scale-16 |
61.9; 66.3; 36.60; 37.70 | 0.241 |
| SECONDARY Patient Disability Assessed With Modified Rankin Scale (mRs) |
2.5; 1.83; 3.60; 3.63 | 0.004 sig |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04835363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.