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NCT Number: NCT06919315

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO-OP intervention

Behavioral

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 practice

Behavioral

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.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: Baseline, up to 14 weeks, 26 weeks follow-up

Secondary outcomes

  1. Assessment of Motor and Process Skills (AMPS) - ADL performance quality

    Time frame: Baseline, up to 14 weeks, 26 weeks follow-up

    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

  2. EuroQol-5 Domain (EQ-5D-5L)

    Time frame: Baseline, up to 14 weeks, 26 weeks follow-up

  3. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: Baseline, up to 14 weeks, 26 weeks follow-up

  4. World Health Organization Quality Of Life (WHOQOL-bref)

    Time frame: Baseline, up to 14 weeks, 26 weeks follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Louise M Nielsen

CONTACT

[email protected]

+4587552413

Sponsors and collaborators

Lead sponsor

Louise Møldrup Nielsen

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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