Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

NCT05829421 | Completed DMC

• 1 other identifier: H-22066840
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke; Cognitive Impairment

Keywords

occupational therapy; neuropsychology; stroke rehabilitation; cognitive rehabilitation; activities of daily living (ADL)

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke

Secondary Outcomes (4)

• 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

• 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

• Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke

  At 3 months poststroke

• Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.

  At 3 months poststroke

Other Outcomes (3)

• Forms collecting feedback from project staff

  Through study completion, an average of 1 year

• Work meetings collecting feedback from project staff

  Through study completion, an average of 1 year

• Semi-structured interviews collecting feedback from patient and caregivers

  Through study completion, an average of 1 year

Study Arms (1)

Impairment-specific occupational therapy (OT) intervention

EXPERIMENTAL

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

Interventions

Impairment-specific occupational therapy (OT) intervention OTHER

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.

Impairment-specific occupational therapy (OT) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first-ever symptomatic stroke,
• age ≥ 18 years,
• residence in Frederiksberg Municipality, Denmark,
• independent in pre-stroke everyday life (≤ 2 points on the modified Rankin Scale, mRS),
• experiencing problems in performing ADLs due to cognitive impairment; these problems are expected to still be present at hospital discharge,
• medical condition allows commencement of rehabilitation focused on ADL and cognition
• fully aware or mild-to-moderate unawareness of deficits (≤ 2 points on the Bisiach Anosognosia Scale, BAS),
• a global cognitive function corresponding to ≥ 17 points on the Montreal Cognitive Assessment, MoCA,
• ≤ 10 points on the depression subscale of the Hospital Anxiety and Depression Scale, HADS,
• able to provide informed consent, as evaluated by the recruiting healthcare professional(s),
• logistically possible to perform baseline assessments and create an individualised intervention plan during hospital stay
• provides informed consent

You may not qualify if:

• psychiatric conditions causing difficulties or preventing participation, as evaluated by the recruiting health care professional(s)
• communication problems causing difficulties or preventing participation, as evaluated by the recruiting healthcare professional(s)
• CAREGIVERS:
• appointed as close carer (by a patient who consented to participate),
• age ≥18y,
• provides informed consent.
• 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:
• appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres,
• provides informed consent.
• \- unable to to follow a preliminary English version of the intervention manual.

Sponsors & Collaborators

• Emma Ghaziani: lead
• Rigshospitalet, Denmark: collaborator
• The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark: collaborator
• The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark: collaborator
• Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark: collaborator

Study Sites (4)

Bispebjerg and Frederiksberg Hospital

Copenhagen, 2400, Denmark

Location

Neurorehabilitation Centre Østervang

Frederiksberg, 2000, Denmark

Location

the Day Rehabilitation Centre

Frederiksberg, 2000, Denmark

Location

the Inpatient Rehabilitation Centre

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hanne Christensen, Professor

  Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoc, OT

Model Details: Feasibility study, non-randomised. An adaptive approach will be used to optimise the intervention content and study conduct as feasibility data are cumulated

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 25, 2023
• Study Start: May 25, 2023
• Primary Completion: March 29, 2024
• Study Completion: October 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)