An interventional study of Impairment-specific occupational therapy (OT) intervention in Cognitive Impairment and Stroke, sponsored by Emma Ghaziani. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Emma Ghaziani · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate feasibility aspects of an intervention targeting problems in managing daily tasks due to mild-to-moderate poststroke cognitive impairments. We will specifically address uncertainties related to intervention content and delivery, and trial design and conduct.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 8 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →This is the only study on the registry with Emma Ghaziani as lead sponsor.
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PATIENTS:
Inclusion criteria:
Exclusion criteria:
CAREGIVERS:
Inclusion criteria:
Exclusion criteria:
-communication problems or other issues causing difficulties in participation as evaluated by the recruiting healthcare professional(s).
Patients without a close carer will not be excluded.
CLINICAL STAFF:
Inclusion criteria:
Exclusion criteria:
- unable to to follow a preliminary English version of the intervention manual.
Patients receive an impairment-specific OT intervention targetting problems in managing activities of daily living (ADL) due to mild-to-moderate poststroke cognitive impairments. The intervention is initiated in the stroke unit as soon as patients' medical condition allows it, and it is delivered 3 times per week until 3 months poststroke. After hospital discharge, the intervention continues in community settings.
Other: Impairment-specific occupational therapy (OT) intervention
In parallel with standard practice, patients receive an OT intervention adapted to the specific underlying cognitive impairments that are likely to disturb their performance of ADLs. The intervention is individualised through a 3-step process: a) a list of dysfunctional ADL process skills is forwarded by the OT to the neuropsychologist (NP), b) the NP identifies the cognitive impairments which are most likely to cause the dysfunctional ADL process skills through a cognitive assessment, c) based on the identified cognitive impairments, the NP and the OT select in collaboration the cognitive strategies that are most likely to benefit the individual patient from a pre-prepared intervention manual. Because of the large heterogeneity in how cognitive impairments impact on ADL performance, the exact way of implementing the selected cognitive strategies into the practice of the individual patient is left to the OT´s clinical judgement.
Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
The AMPS is a standardised observation-based instrument measuring two aspects of ADL performance: ADL motor skills (reflecting physical effort) and ADL process skills (reflecting efficiency, safety, and independence). The quality of each skill is evaluated on a 4-level scale. Based on Rasch statistics, the AMPS software converts these raw scores into two overall linear ADL scores (expressed in logits): an ADL motor score, and an ADL process score. Several studies support the AMPS' validity and reliability in both stroke populations. The AMPS is an OT-specific instrument and requires user certification.
Time frame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
The AMPS is a standardised observation-based instrument measuring two aspects of ADL performance: ADL motor skills (reflecting physical effort) and ADL process skills (reflecting efficiency, safety, and independence). The quality of each skill is evaluated on a 4-level scale. Based on Rasch statistics, the AMPS software converts these raw scores into two overall linear ADL scores (expressed in logits): an ADL motor score, and an ADL process score. Several studies support the AMPS' validity and reliability in both stroke populations. The AMPS is an OT-specific instrument and requires user certification.
Time frame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Change from pre-stroke in global disability (assessed by the modified Rankin Scale, mRS) at 3 months. Min-max values: 0 (no symptoms at all) - 6 (dead)
Stroke-specific measure of global disability. Min-max values: 0 (no symptoms at all9 - 6 (dead).
Time frame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke
Generic measure of health-related quality of life. It contains six subscales: mobility, self-care, usual activities, pain/discomfort, anxiety depression and perceived health. Perceived health is measured on a 0-100 scale (0: worst outcome, 100: best outcome). Each of remaining subscales are scored on a 5-level ordinal scale (1: best outcome, 5: worse outcome). The result for each subscale will be presented separately.
Time frame: At 3 months poststroke
Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.
The CBS is a 22-item scale that assess subjectively experienced burden by caregiver's to chronically disabled persons. The caregiver is asked to tick one of the four boxes (not at all, seldom, sometimes, often) score 1 to 4 for each question. The instrument comprises five factors: general strain, isolation, disappointment, emotional involvement and environment. A mean value is calculated for each factor including the following items: General strain: 1, 3, 4, 5, 7, 10, 14, and 19 Isolation: 8, 12, and 22 Disappointment: 2, 13, 18, 20, and 21 Emotional involvement: 6, 11, and 16 Environment: 9, 15, and 17
Time frame: At 3 months poststroke
Forms collecting feedback from project staff
Based on feedback from the project staff collected through forms, the investigators will explore feasibility aspects such as: OTs' acceptability of the intervention, piloting the individualisation of the intervention, piloting the intervention delivery, refining the intervention manual, estimating participant recruitment and retention for a future RCT, and piloting outcome measures. .
Time frame: Through study completion, an average of 1 year
Work meetings collecting feedback from project staff
Based on feedback from the project staff collected through work meetings, the investigators will explore feasibility aspects such as: OTs' acceptability of the intervention, piloting the individualisation of the intervention, piloting the intervention delivery, and refining the intervention manual.
Time frame: Through study completion, an average of 1 year
Semi-structured interviews collecting feedback from patient and caregivers
Based on feedback from patients and caregivers, the investigators will explore the patients' acceptability of the intervention.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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