Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Stroke
• Interventions: Other: Impairment-specific occupational therapy (OT) intervention

• Registration Number: NCT05829421
• Lead Sponsor: Emma Ghaziani

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-25
• Status Verified: 2023-05
• Study Start: 2023-05-25
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2025-05-02
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Impairment-specific occupational therapy (OT) intervention	Impairment-specific occupational therapy (OT) intervention	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke	At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 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.

Secondary Outcome Measures

Name	Time	Method
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)	At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke	Stroke-specific measure of global disability. Min-max values: 0 (no symptoms at all9 - 6 (dead).
Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.	At 3 months poststroke	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
Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke	At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 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.
Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke	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.

Trial Locations

Locations (4)

Bispebjerg and Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark

Neurorehabilitation Centre Østervang; 🇩🇰 Frederiksberg, Denmark

the Inpatient Rehabilitation Centre; 🇩🇰 Frederiksberg, Denmark

the Day Rehabilitation Centre; 🇩🇰 Frederiksberg, Denmark