Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments (NIOTI-stroke)

Feasibility of a Neuropsychologically Informed Occupational Therapy Intervention Targeting Decreased Ability to Perform Activities of Daily Living in People With Poststroke Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cognitive Impairment
• Intervention / Treatment: Other: Impairment-specific occupational therapy (OT) intervention

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg and Frederiksberg Hospital
  • Frederiksberg, Denmark, 2000
    • Neurorehabilitation Centre Østervang
  • Frederiksberg, Denmark, 2000
    • the Day Rehabilitation Centre
  • Frederiksberg, Denmark, 2000
    • the Inpatient Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

PATIENTS:

Inclusion criteria:

• 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

Exclusion criteria:

• 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:

Inclusion criteria:

• appointed as close carer (by a patient who consented to participate),
• age ≥18y,
• provides informed consent.

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:

• appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres,
• provides informed consent.

Exclusion criteria:

- unable to to follow a preliminary English version of the intervention manual.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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	At 3 months poststroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. .	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.	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Emma Ghaziani
• Collaborators: Rigshospitalet, Denmark; The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark; The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark; Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark
• Investigators: Principal Investigator: Hanne Christensen, Professor, Bispebjerg and Frederiksberg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: neuropsychology; cognitive rehabilitation; occupational therapy; stroke rehabilitation; activities of daily living (ADL)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction; Investigative Techniques; Methods
• Other Study ID Numbers: H-22066840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No