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Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)

Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06919315
Enrollment
50
Registered
2025-04-09
Start date
2025-05-02
Completion date
2027-07-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Rehabilitation, CO-OP, Occupational Therapy

Brief 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. 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.

Interventions

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.

BEHAVIORALUsual practice

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.

Sponsors

Louise Møldrup Nielsen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Stroke or traumatic brain injury * Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation * Having at least on ADL performance issue

Exclusion criteria

* Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions. * Alkohol or drug abuse * Not speeking or understanding Danish

Design outcomes

Primary

MeasureTime frame
Canadian Occupational Performance Measure (COPM)Baseline, up to 14 weeks, 26 weeks follow-up

Secondary

MeasureTime frameDescription
Assessment of Motor and Process Skills (AMPS) - ADL performance qualityBaseline, up to 14 weeks, 26 weeks follow-upParticipants 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
EuroQol-5 Domain (EQ-5D-5L)Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Quality Of Life (WHOQOL-bref)Baseline, up to 14 weeks, 26 weeks follow-up

Countries

Denmark

Contacts

CONTACTLouise M Nielsen
lmn@via.dk+4587552413

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026