18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Quality of LifePrimary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months)
Group
Value
95% CI
Control Group
3.41
± 0.69
OT Intervention.
3.91
± 0.70
Before intervention (baseline)
Group
Value
95% CI
Control Group
2.51
± 0.75
OT Intervention.
2.67
± 0.72
Patient's Sensory-motor SkillsSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months)
Group
Value
95% CI
Control Group
111.10
± 17.6
OT Intervention.
117
± 12.6
Before intervention (baseline).
Group
Value
95% CI
Control Group
99.80
± 22.60
OT Intervention.
102.00
± 18.90
Patient Perceptual-cognitive SkillsSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
20.1
± 7.06
OT Intervention.
24.8
± 6.58
Before intervention (baseline).
Group
Value
95% CI
Control Group
16.6
± 7.33
OT Intervention.
18.6
± 7.16
Patient Communication SkillsSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
116
± 31.1
OT Intervention.
137
± 24.2
Before intervention (baseline).
Group
Value
95% CI
Control Group
109.00
± 37.00
OT Intervention.
122.00
± 27.30
Depression of the PatientSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
15.3
± 10.48
OT Intervention.
8.4
± 8.88
Before intervention (baseline).
Group
Value
95% CI
Control Group
13.60
± 9.76
OT Intervention.
11.23
± 9.11
Patient MobilitySecondary· Before intervention (baseline) and after intervention (3 months)
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.
After intervention (3 months).
Group
Value
95% CI
Control Group
12.4
± 4.83
OT Intervention.
14.3
± 12.8
Before intervention (baseline).
Group
Value
95% CI
Control Group
28.40
± 17.68
OT Intervention.
29.00
± 12.90
Patient Functional BalanceSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
45.3
± 11.7
OT Intervention.
47
± 11.1
Before intervention (baseline).
Group
Value
95% CI
Control Group
22.70
± 17.90
OT Intervention.
27.60
± 14.60
Anxiety of the PatientSecondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
11.3
± 9.4
OT Intervention.
5.5
± 7.94
Before intervention (baseline).
Group
Value
95% CI
Control Group
11.50
± 10.88
OT Intervention.
8.47
± 10.96
Patient Functional Independence Assessed With Barthel IndexSecondary· Before intervention (baseline) and after intervention (3 months)
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.
After intervention (3 months).
Group
Value
95% CI
Control Group
85
± 16.7
OT Intervention.
90
± 14.9
Before intervention (baseline).
Group
Value
95% CI
Control Group
52.5
± 21
OT Intervention.
54.7
± 20.5
Patient Functional Independence Assessed With Stroke Impact Scale-16Secondary· Before intervention (baseline) and after intervention (3 months)
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.
After intervention (3 months).
Group
Value
95% CI
Control Group
61.9
± 12.6
OT Intervention.
66.3
± 10.7
Before intervention (baseline).
Group
Value
95% CI
Control Group
36.60
± 14.00
OT Intervention.
37.70
± 11.00
Patient Disability Assessed With Modified Rankin Scale (mRs)Secondary· Before intervention (baseline) and after intervention (3 months)
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).
After intervention (3 months).
Group
Value
95% CI
Control Group
2.5
± 1.04
OT Intervention.
1.83
± 1.05
Before intervention (baseline).
Group
Value
95% CI
Control Group
3.60
± 0.77
OT Intervention.
3.63
± 0.80
Caregiver Burden.Secondary· Before intervention (baseline) and after intervention (3 months)
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.
After intervention (3 months).
Group
Value
95% CI
Control Group - Caregivers
3.91
± 0.70
OT Intervention Group - Caregivers
3.41
± 0.69
Before intervention (baseline).
Group
Value
95% CI
Control Group - Caregivers
12.8
± 12.6
OT Intervention Group - Caregivers
14.5
± 6.91
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by University of Malaga
Last refreshed: 10 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04835363.