Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Stroke

• 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

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 Day Rehabilitation Centre; 🇩🇰 Frederiksberg, Denmark

the Inpatient Rehabilitation Centre; 🇩🇰 Frederiksberg, Denmark