StrokeNCT06919315
Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)
A study testing CO-OP intervention and Usual practice in people with Stroke, run by Louise Møldrup Nielsen at 1 site in Denmark.
Trial summary
The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (18+) with accuired brain injury when applied in Danish rehabilitation context. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CO-OP intervention and Usual practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 2 May 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke or traumatic brain injury
- Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation
- Having at least on ADL performance issue
Who cannot join
- Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
- Alkohol or drug abuse
- Not speeking or understanding Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rehabilitation center
Viborg, 8800
Mie Tholstrup, +4520695540, kmk@viborg.dk
About this study
Official title: Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context
The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (18+) with accuired brain injury when applied in Danish rehabilitation context. The primary research question is: What is the effectiveness of the CO-OP approach on improvement of performance of daily activities (ADL) and quality of life compared to usual rehabilitation practice.
Participants in the intervention group will recieve the CO-OP intervention as part of their rehabilitation in the following phases:
Read more
Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.
Participants in the control group will recieve usual rehabilitation practice in the following phases:
Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.
- Conditions
- Stroke
- Being tested
- CO-OP intervention, Usual practice
- Keywords
- Stroke, Rehabilitation, CO-OP, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OP interventionBehavioural
CO-OP intervention: Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.
Usual practiceBehavioural
Usual practice: Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: CO-OP intervention |
| Control | Active comparator | Not described Receives: Behavioral: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
Measured: Baseline, up to 14 weeks, 26 weeks follow-up
Secondary outcomes (4)
Assessment of Motor and Process Skills (AMPS) - ADL performance quality
Participants ADL performance quality will be measured with the Occupational Therapy assesment instrument, AMPS. Both process and motor skills in ADL performance will be measured and reported separately
Measured: Baseline, up to 14 weeks, 26 weeks follow-up
EuroQol-5 Domain (EQ-5D-5L)
Measured: Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured: Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Quality Of Life (WHOQOL-bref)
Measured: Baseline, up to 14 weeks, 26 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start2 May 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental superiority trial will compare a usual practice (control) group and a CO-OP intervention group. The study will be conducted in two phases. In phase I, usual practice is delivered and in phase II, CO-OP is delivered.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louise Møldrup Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louise Møldrup Nielsen, VIA University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919315
- Sponsor's protocol ID
- CO-OP project
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context
- ClinicalTrials.gov ID
- NCT06919315
- Acronym / sponsor ID
- CO-OP project
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, CO-OP, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Louise Møldrup NielsenUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (18+) with accuired brain injury when applied in Danish rehabilitation context. The primary research question is: What is the effectiveness of the CO-OP approach on improvement of performance of daily activities (ADL) and quality of life compared to usual rehabilitation practice.
Participants in the intervention group will recieve the CO-OP intervention as part of their rehabilitation in the following phases:
Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.
Participants in the control group will recieve usual rehabilitation practice in the following phases:
Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental superiority trial will compare a usual practice (control) group and a CO-OP intervention group. The study will be conducted in two phases. In phase I, usual practice is delivered and in phase II, CO-OP is delivered.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: CO-OP intervention |
| Control | Active comparator | Behavioral: Usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke or traumatic brain injury
- Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation
- Having at least on ADL performance issue
Key exclusion criteria (3 listed)
- Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
- Alkohol or drug abuse
- Not speeking or understanding Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-OP interventionCO-OP intervention: Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory. | Behavioural | Experimental |
| Usual practiceUsual practice: Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included. | Behavioural | Control |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, up to 14 weeks, 26 weeks follow-up
4 secondary outcomes
Assessment of Motor and Process Skills (AMPS) - ADL performance quality
Time frame: Baseline, up to 14 weeks, 26 weeks follow-up
EuroQol-5 Domain (EQ-5D-5L)
Time frame: Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Quality Of Life (WHOQOL-bref)
Time frame: Baseline, up to 14 weeks, 26 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP intervention and Usual practice in people with Stroke, run by Louise Møldrup Nielsen at 1 site 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise M Nielsen (+4587552413, lmn@via.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: Baseline, up to 14 weeks, 26 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.