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Cognitive ImpairmentNIOTI-strokeNCT05829421

Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

A study testing Impairment-specific occupational therapy (OT) intervention in people with Cognitive Impairment and Stroke, run by Emma Ghaziani at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Impairment, Stroke
What is being tested?
Impairment-specific occupational therapy (OT) intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesDenmark
Study dates
25 May 2023to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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
  • appointed as close carer (by a patient who consented to participate),
  • age ≥18y,
  • provides informed consent.
  • appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres,
  • provides informed consent.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Bispebjerg and Frederiksberg Hospital

    Copenhagen, 2400

  • Neurorehabilitation Centre Østervang

    Frederiksberg, 2000

  • the Day Rehabilitation Centre

    Frederiksberg, 2000

  • the Inpatient Rehabilitation Centre

    Frederiksberg, 2000

Other trials in Denmark

About this study

Official title: 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.

Being tested
Impairment-specific occupational therapy (OT) intervention
Keywords
occupational therapy, neuropsychology, stroke rehabilitation, cognitive rehabilitation, activities of daily living (ADL)
Medical subject headings
Cognitive Dysfunction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impairment-specific occupational therapy (OT) interventionOther

    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.

Study groups in NCT05829421
Study groupRoleWhat they receive
Impairment-specific occupational therapy (OT) interventionExperimentalPatients 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.
Receives: Other: Impairment-specific occupational therapy (OT) intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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).

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

  3. 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.

    Measured: At 3 months poststroke

  4. 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

    Measured: At 3 months poststroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start25 May 2023
  3. Primary completion29 Mar 2024
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study, non-randomised. An adaptive approach will be used to optimise the intervention content and study conduct as feasibility data are cumulated
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829421
Sponsor's protocol ID
H-22066840
Acronym
NIOTI-stroke
Status last verified
Nov 2025
First submitted
6 Mar 2023
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Impairment-specific occupational therapy (OT) intervention in people with Cognitive Impairment and Stroke, run by Emma Ghaziani at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke (time frame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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