Comparing cognitive orientation to daily occupational performance and motivational interviewing in stroke rehabilitation: A protocol for a randomized controlled trial

Abstract

Background:

Long-term disability following stroke significantly affects functional abilities and daily living activities. This protocol outlines a planned three-arm randomized controlled trial to compare effects of Motivational Interviewing (MI) and Cognitive Orientation to daily Occupational Performance (CO-OP) on occupational performance among individuals with chronic stroke.

Method:

Sixty individuals with chronic stroke will be randomly assigned to one of three groups: CO-OP, MI, or control. The primary outcome of interest is occupational performance, evaluated using the Canadian Occupational Performance Measure (COPM) and Performance Quality Rating Scale (PQRS). Secondary outcomes include functional independence, measured by Functional Independence Measurement (FIM), and self-efficacy, assessed with General Self-Efficacy Scale (GSES). Assessments will be conducted at baseline, postintervention (5 weeks), and 1-month follow-up. Data will be analyzed using SPSS version 26 (IBM Corp., Armonk, NY, USA). The Shapiro–Wilk test will assess data normality. For quantitative variables, ANOVA or Kruskal–Wallis tests will be used depending on distribution. Qualitative variables will be analyzed using Chi-square or Fisher’s exact test.

Discussion:

This protocol describes the methodology for comparing the effectiveness of CO-OP and MI in improving occupational performance in individuals with stroke. The findings from the planned study will inform future large-scale trials and may guide clinical decision-making in rehabilitation settings.

Trial Registration:

IRCT20180515039676N1.

Background

Chronic diseases, such as stroke, have a profound effect on long-term functional abilities and independent living (Heeb Desai et al., 2023). As the second leading cause of mortality, stroke significantly impacts global health (Prust et al., 2024). Global projections indicate a substantial increase in the burden of stroke in the coming decades, with anticipated rise of approximately 81% in incident cases and 71% in prevalent cases expected between 2021 and 2050 (Cheng et al., 2024). Poststroke, individuals often face motor, sensory, emotional (Kwakkel et al., 2023), motivational (Tynterova et al., 2024), and cognitive impairments (Cramer et al., 2023), severely limiting their daily activities and occupational performance (Sorita et al., 2011). These impairments, which affect approximately 60% of stroke survivors (Gittins et al., 2021), significantly hinder their ability to engage in meaningful activities, tasks, and roles that influence self-care, productivity, and leisure. As a result, the dynamic interaction between an individual, their environment, and activities central to occupational performance is compromised by the multifaceted challenges posed by stroke-related impairment (Baum, 2012).

Effective long-term rehabilitation depends on cognitive factors (Giles et al., 2019) and motivation (Rajan, 2022). There is a growing body of literature highlighting the effectiveness of motivation-based and cognitive strategies in enhancing occupational performance outcomes (Camillieri, 2019). Motivational Interviewing (MI; Binder et al., 2019) and Cognitive Orientation to Daily Occupational Performance (CO-OP) are proven strategies to enhance occupational performance (Kiriakou & Psychouli, 2024). Both interventions are client-centered (Camillieri, 2019), adaptable to various cultural contexts (Saeidi Borujeni et al., 2020; Self et al., 2023), and cost-effective, making them suitable for widespread use (Camillieri, 2019).

MI is a counseling approach that boosts motivation for positive behavior change through empathic listening and resolving ambivalence. Its principles include collaboration, evocation, autonomy, empathy, and self-efficacy (Miller, 2023). CO-OP is a performance-based approach that uses guided discovery and cognitive strategies to improve motor-based tasks. It focuses on skill acquisition, cognitive strategies, generalization, and transfer (Polatajko, Mandich, Miller, et al., 2001).

In recent years, various studies have highlighted the effectiveness of MI (Chen et al., 2020) and CO-OP (Kiriakou & Psychouli, 2024) in improving occupational performance among stroke survivors. Although both interventions have demonstrated beneficial outcomes when applied separately, no study has yet been found that investigates a comparative advantage between these two approaches. By systematically evaluating and comparing these two evidence-based approaches, this research will provide valuable insights into which strategy may be more effective in optimizing rehabilitation outcomes for individuals living with long-term consequences of stroke.

This protocol outlines the design of an exploratory three-arm randomized controlled trial (RCT) aiming to compare the effects of MI and CO-OP on occupational performance among individuals with chronic stroke.

Given the exploratory nature of this study, no formal null or alternative hypotheses are proposed at this stage. Instead, the study seeks to explore potential differences in the impact of MI and CO-OP on occupational performance.

The findings will be used to generate hypotheses and inform the design and sample size calculations for future confirmatory trials.

Ethical considerations and trial registration

Ethics approval was granted by the University of Social Welfare and Rehabilitation Sciences (IR.USWR.REC.1402.122) in 2023, with the registration code IRCT20180515039676N1.

Method

Study design

An exploratory three-arm randomized controlled trial (RCT) will be conducted in accordance with the SPIRIT 2013 statement (Dai et al., 2019), aiming to compare the effects of MI and CO-OP on occupational performance in individuals with chronic stroke. The primary objective is to generate preliminary evidence regarding the comparative effectiveness of these interventions, which may inform future confirmatory studies. This trial is reported in accordance with the CONSORT 2010 guidelines (Schulz et al.,2010) This trial is reported in accordance with the CONSORT 2010 guidelines (Schulz et al.,2010).

Eligibility criteria

The inclusion criteria are (a) Diagnosed with chronic stroke (at least 6 month poststroke) by a neurologist; (b) Over 18 years old; (c) cognitive ability above 22 on the Montreal Cognitive Test; (d) scores between 5 and 18 on the short form of the Beck’s Depression Inventory (BDI); (e) at least at the third stage of Brunnstrom; (f) no verbal comprehension deficits, such as global aphasia; and (g) referred by an occupational therapist for difficulties in occupational performance.

Exclusion criteria are (a) experiencing a recurrent stroke or another major illness.

Compared to acute and sub-acute stroke care, it is crucial to focus on to the long-term needs of individuals with chronic stroke, as these needs have often been overlooked in conventional rehabilitation approaches (Rudberg et al., 2021). Therefore, it seems necessary to investigate the effectiveness of MI and CO-OP approaches that focus on the components of the interventions using cognitive strategies and enhancing motivation instead of focusing on physical aspects. It is worth mentioning that addressing these factors may lead to more comprehensive and effective stroke recovery outcomes.

Settings and locations

The study will be conducted at rehabilitation centers affiliated with Isfahan University of Medical Sciences, Iran. These hospitals are centrally located within the province and serve patients from various geographic areas, including both urban and rural regions.

Recruitment

Participants will be recruited from hospitals affiliated with Isfahan University of Medical Sciences, Iran. Given that the recruitment sites serve individuals from diverse geographic backgrounds, this diversity is expected to contribute to the representativeness and generalizability of the study findings within the regional context.

Consent process

Written informed consent will be obtained from participants who agree to take part in the study. Following this, individuals who fulfill the inclusion criteria based on initial assessments will be formally enrolled in the research.

Interventions

CO-OP group: The CO-OP intervention will be conducted in 1-hr sessions, twice weekly over a 5-week period. The 20 participants will receive the CO-OP intervention in addition to conventional rehabilitation. The intervention will be implemented by a therapist trained to ensure adherence to the protocol established by Polatajko (Polatajko, Mandich, Miller, et al., 2001; Polatajko, Mandich, Missiuna, et al., 2001). Prior to first session, the therapist with the participant will identify three goals using the COPM. In the initial session, the therapist will introduce the global cognitive strategy to the participant. From the second to ninth sessions, the goal-plan-do-check strategy, which serves as the primary framework for problem-solving, will be employed repeatedly to achieve the participant’s selected goals. This process aims to facilitate activity acquisition and the development of cognitive strategies. To formulate a plan for goal attainment, the participant will address the chosen goals under the therapist’s guidance. The participant will then implement the plan and subsequently evaluate the achievement of the goal. If the goal is not met, the therapist will assist the participant in analyzing the performance to modify the existing plan or develop a new one (Table 1).

Table 1.

CO-OP protocol.

Session	Description
Session 1	Preparation • Establish therapeutic contact with the participant. • Provide and review the Daily Activity Log in collaboration with the therapist and the participant with chronic stroke. • Discuss the COPM and talk about three goals through the cooperation of the therapist and the participant.
Session 2	Introduction of Global Cognitive Strategy • Introduce the Global Cognitive Strategy: GDPC. • The therapist presents the Goal-Plan-Do-Check using colored cards to the participant. • The therapist and participant map GDPC to a familiar task. • The participant with stroke discusses the use of GPDC at home with the therapist.
Sessions 3–9	Acquisition • Begin DPA from the start. • Assist the participant in achieving and applying the global cognitive strategy: Goal-Plan-Do-Check. • Help the participant with stroke discover DSS and apply them in skill acquisition. • Utilize the principles of activation. • Teach the caregiver (if the participant has one) about Goal-Plan-Do-Check and Domain-Specific Strategies, and their ongoing role in facilitating the Cognitive Strategy of the participant.
Session 10	• Encourage the participant to generalize and transfer global and domain-specific strategies: GPDC and DSS • Review and reinforce the use of the CO-OP approach and cognitive strategies with the participant.

Note. COPM = Canadian Occupational Performance Measure; CO-OP = Cognitive orientation to daily occupational performance; DPA = Dynamic Performance Analysis; DSS = Domain-Specific Strategies; GDPC = Goal-Plan-Do-Check.

MI group: The MI intervention will be conducted in 1-hr sessions, twice weekly over a 5-week period. The 20 participants will receive the MI intervention in addition to conventional rehabilitation. The therapist administering the intervention has completed an MI course and has 5 years of experience in the field. The MI sessions will emphasize the use of open-ended questions, feedback, counseling, affirmation, reflection, reframing, and support. The sessions will start with an introduction to stroke, its causes, and its progression. The intervention will then focus on describing a typical day, examining short-term and long-term challenges, adaptive behaviors, and compensatory strategies. The therapist will assist participants in identifying their problems and, through support, will enhance their optimism and self-efficacy, enabling them to find their own solutions. The sessions will continue with an emphasis on identifying the participants’ desired goals and the strategies to achieve them, fostering internal motivation and facilitating changes to reach the desired outcomes (Table 2).

Table 2.

MI protocol.

Session	Description
Session 1 (Pre-intention)	• Discussing treatment goals and informing the participant using the COPM.
Session 2 (Pre- intention)	• Talking with participants about their stroke, emphasizing the benefits of rehabilitation interventions.
Session 3 (Intention)	• Identifying the participant’s concerns related to stroke, including necessary supports and abilities.
Session 4 (Intention)	• Asking participants to describe a typical day to uncover personal challenges and goals.
Session 5 (Decision)	• Helping participants boost optimism and self-efficacy in finding solutions.
Session 6 (Decision)	• Focusing on goals and assisting in the pursuit of personal objectives set in previous steps.
Session 7 (Action)	• Discussing with the participants about how their self-devised solutions are working toward achieving personal goals.
Session 8 (Action)	• Providing help and support from the therapist to participants in finding solutions to achieve personal goals, along with positive feedback.
Session 9 (Maintenance)	• Identifying barriers to maintaining motivation in participants with chronic stroke. • Enhancing the motivation of participants and supporting the continuation of their activities.
Session 10 (Maintenance)	• Boosting the motivation of participants, supporting their ongoing activities, and summarizing discussions during sessions.

Note. COPM = Canadian Occupational Performance Measure; MI = Motivational Interviewing.

Control group: The conventional rehabilitation will be conducted in 1-hr sessions, twice weekly over a 5-week period. The 20 participants in the control group will receive occupational therapy sessions. Based on the results from the PQRS, COPM, and personalized goals for each participant, the usual care occupational therapy sessions will incorporate a combination of functional and task-based exercises, along with component-based training.

In all three groups, the COPM, Functional Independence Measurement (FIM) and GSES assessments will be conducted at baseline, immediately after intervention, and 1 month later. Performance video recordings will also be made at these intervals to enhance PQRS scores.

In the initial assessment using the COPM, five occupational performance goals are identified for each participant. During the intervention, participants will focus on three of these goals, which they select. The remaining two goals, which are not directly targeted during the intervention, will serve to evaluate generalization and transfer of skills. Performance and satisfaction ratings will be reassessed immediately postintervention and at the 1-month follow-up.

Participants’ activities will be video-recorded using the PQRS, with written informed consent obtained beforehand and assurance of confidentiality. Videos will be destroyed 6 months after the study concludes, ensuring dignity and respect throughout the filming process to prevent any embarrassment. Two experienced occupational therapists will use a 10-point scale to evaluate participant’s performance quality, consistently assessing their ability to perform activities.

Outcomes and assessments

Baseline characteristics

Once written informed consent is obtained, the assessor will complete the demographic questionnaire, the Montreal Cognitive Assessment (MoCA), and the BDI with the participant.

The primary outcomes of the study will include changes in self-reported occupational performance, measured by the Canadian Occupational Performance Measure (COPM), and observed task performance quality, assessed using the Performance Quality Rating Scale (PQRS). Both outcomes will be evaluated from baseline to postintervention.

Secondary outcomes will include changes in functional independence, as measured by the FIM, and self-efficacy, assessed with the GSES.

Demographic information encompasses age, gender, education level, marital status, employment status, date of stroke, type of stroke, history of other diseases, family history of stroke, history of rehabilitation services received, and medications.

The MoCA is a quick screening tool for cognitive impairments, consisting of 12 subscales and a 30-point test. It takes approximately 10 min to administer. The MoCA has been translated into Persian, with Emsaki et al. reporting a Cronbach’s alpha coefficient of 77% and a concurrent validity of 79% (Emsaki et al., 2011).

The BDI was developed to assess the severity of depression and takes about five to 10 min to complete. The BDI has been translated into Persian, with Khaledian et al. (2013) reporting reliability and validity between 0.73 and 0.93.

Primary outcome measures

The primary outcomes are changes in self-identified occupational performance goals and observed task performance quality, which were selected to reflect the core objectives of interventions. These outcomes are measured using the COPM and the PQRS, respectively.

The COPM is a client-centered tool that evaluates three performance areas: self-care, productivity, and leisure. Participants identify their occupational performance issues and rate their performance and satisfaction on a 10-point Likert scale (Dehghan et al., 2015; McColl et al., 2000). The COPM has been translated into Persian, with reported validity of 80.95 ± 0.22, and reliability scores of 0.84 for performance and 0.87 for satisfaction (Dehghan et al., 2015).

The PQRS is an observational tool used to evaluate performance. In this study, ratings will be based on video recordings of the participants performing five selected activities that were chosen by participants in the COPM. The selection of activities for evaluation using the PQRS will be guided by the COPM. During the initial assessment, participants prioritize up to five daily living activities they find most challenging. These activities are then used as targets for intervention and subsequent evaluation using the PQRS. Two evaluators will grade the quality of performance before and after the intervention on a scale from 1 to 10. Martini et al. (2015) reported test–retest reliability above 80 and internal consistency ranging from 0.83 to 0.93.

Secondary outcome measures

Secondary outcome measures, including the FIM and the GSES, are outlined below. These were chosen to evaluate independence and self-efficacy, which aligns closely with the intervention goals.

The FIM includes 13 items related to self-care and five items focused on communication and social cognition. Performance is rated on a seven-point scale, with one indicating maximum dependence and seven indicating independence, resulting in a total possible score ranging from 18 to126. The assessment takes approximately 45 min, depending on the patient’s abilities. Naqdi et al. validated and tested the reliability of the FIM scale in Iran, reporting a Cronbach’s alpha between 0.75 and 0.96, and test–retest reliability between 0.88 and 0.98 (Naghdi et al., 2016).

The GSES includes 10 subscales and measures an individual’s confidence in handling stressors of life. Scores range from 10 to 40 on a Likert scale. The Persian version of the GSES has demonstrated good validity and reliability, with a Cronbach’s alpha of 0.94 (Farnia et al., 2020).

Participant timeline

The total duration of participants’ involvement in the study is approximately 10 weeks, comprising a 5-week intervention period and a 1-month follow-up phase. Participants in the control, CO-OP, and MI groups will attend two sessions per week over the 5-week intervention period, with each session lasting 60 min. This schedule will result in a total of 10 sessions for individuals with chronic stroke.

To recruit participants, the relevant occupational therapy department will be contacted. Eligible participants with stroke will then be reached out to, and research-related information will be shared with them over the phone. If the participants and their caregivers agree, they will be directed to the occupational therapy clinic.

Sample size calculation and handling of dropouts

The sample size for this study was calculated based on a medium-effect size (Cohen’s d = 0.5), and a power of 80%, following the methodology described by Chow et al. (2018). Based on these assumptions, an initial estimate of 17 participants per group was required.

To account for potential participant attrition ( ~15%), the sample size was conservatively adjusted to 20 participants per group, leading to a total sample size of 60 participants. This adjustment follows recommendations from Haghdoost et al. (2011), which advise against inflating the sample size beyond 30% unless there is strong empirical support for higher dropout rates. The planned use of an intention-to-treat (ITT) analysis further supports this approach, as ITT preserves the validity of comparisons even in the presence of dropouts by including all randomized participants regardless of intervention adherence or completion. These calculations ensure sufficient power to detect meaningful differences while maintaining ethical and practical standards in study design.

To ensure robustness and minimize bias due to missing data:

• Our primary statistical analysis will follow the intention-to-treat (ITT) principle, which includes all randomized participants in their originally assigned groups, regardless of protocol adherence or early withdrawal.

• For handling missing data due to dropouts, multiple imputation methods will be applied under the assumption of missing at random (MAR).

Randomization procedure

Allocation concealment

To ensure allocation concealment, sealed, opaque, envelopes prepared with aluminum foil will be used. Each envelope contains a card indicating group assignment based on a pre-generated random sequence. The envelopes will be numbered externally to maintain the order and stored in a secure box. During participant registration, an envelope will be opened sequentially by the occupational therapist responsible for intervention delivery, ensuring that neither the participants nor the assessor are aware of upcoming allocations.

Sequence generation

A random sequence with blocks of six will be generated using www.sealedenvelope.com. This block randomization method ensures balanced group sizes throughout the recruitment period.

Blinding (masking)

All assessments in the study will be conducted by a trained assessor who is unaware of the participants’ group allocation. The therapist administering the interventions across the three groups will be different from the assessor. To ensure ethical integrity and minimize potential bias, two therapists will be involved in administering the interventions. One therapist, proficient in both CO-OP and MI approaches, will handle the interventions for the MI and CO-OP groups. A different therapist will be responsible for administering the interventions for the control group. This arrangement helps to maintain clear delineation between the interventions and enhances the reliability and validity of the study.

Figure 1.

CONSORT study flowchart. Adapted from Schulz et al. (2010).

To minimize the potential for performance bias due to the use of a single therapist for both MI and CO-OP interventions, several strategies have been implemented. First, standardized intervention manuals were developed for both interventions, detailing session objectives, structure, and key techniques. Second, the therapist underwent formal training and certification in both approaches to ensure fidelity in delivery. Third, adherence to protocol will be monitored through regular supervision sessions with experts in MI and CO-OP, during session recordings that were reviewed and corrective feedback provided when necessary.

Assessments will be performed at three distinct time points: initially at baseline, following the completion of the 5-week intervention, and at a 1-month follow-up.

Data management

All personal information will be collected securely and shared exclusively with authorized personnel to ensure participant confidentially. Data will be anonymized using unique participant codes. After completion of the study, all collected information will be archived or destroyed in accordance with institutional data retention policies and ethical regulations. In addition, video recordings of participant activities will be securely stored and deleted 6 months poststudy to maintain privacy and uphold ethical standards during and after the research process.

Statistical analysis

Data analysis approach

The primary analysis will follow the intention-to-treat (ITT) principle, in which all randomized participants will be analyzed according to their originally assigned group, regardless of intervention adherence or completion. Participants who miss two or more consecutive RCT-specific treatment sessions will be classified as dropouts and reported in accordance with CONSORT guidelines (Schulz et al., 2010); however, they will remain in the analysis under the ITT to preserve randomization and reduce bias.

Statistical tests and procedures

All statistical analyzes will be conducted using SPSS version 26 software. The Shapiro–Wilk test (P > .05) will assess the normality of quantitative data. Normally distributed continuous variables will be reported as mean (SD), while non-normally distributed one will be shown as median, categorical variables will be expressed as frequencies or percentages. To compare qualitative variables among groups, the Chi-square test or Fisher’s exact test will be used. For quantitative variables, ANOVA or Kruskal–Wallis test will be applied. Repeated measures of ANOVA will analyze pretest, posttest, and follow-up scores, with Tukey’s post hoc tests for pairwise group comparisons. If there is missing data, a linear mixed model will be used for analysis, and if the data are not normally distributed, the generalized estimating equation will be employed.

Discussion

The increasing prevalence of stroke and the growing demand for effective rehabilitation strategies underscore the need for high-quality clinical trials to inform evidence-based practice (Stinear et al., 2020). This study compares two cognitive-based interventions_ MI and CO-OP _ that aim to enhance occupational performance in individuals with chronic stroke through distinct mechanisms. CO-OP is grounded in the principles of experience-dependent neuroplasticity and task-specific learning (Kiriakou & Psychouli, 2024), targeting motor learning challenges that are central to poststroke recovery (Polatajko, Mandich, Miller, et al., 2001). In contrast, MI focuses on intrinsic motivation as a key driver of behavioral change, engaging the mirror neuron system to support readiness for action (Di Pellegrino et al., 1992; Schmidt et al., 2021). Motivation has been identified to as a critical factor influencing engagement in rehabilitation activities, even when physical capacity exists (Miller, 2023).

Despite differing theoretical foundations, both interventions have demonstrated potential in improving self-efficacy, functional outcomes, and client engagement in rehabilitation (Camillieri, 2019). CO-OP emphasizes strategy use and problem-solving to achieve meaningful tasks, while MI facilitates behavior change by addressing personal readiness and autonomy (Miller & Rose, 2009). By focusing on individual goals using client-centered tools such as the COPM, this trial aims to enhance applicability across diverse needs and support personalized rehabilitation planning. This trial is designed with methodological rigor to ensure both internal and external validity, which will enhance its impact on future clinical practice in occupational therapy. By employing a randomized controlled design, standardized intervention protocols, and blinded outcome assessment, the study minimizes bias and strengthens internal validity. The use of intention-to-treat analysis, clear inclusion/exclusion criteria, and fidelity checks further supports the reliability and reproducibility of findings. In terms of external validity, participants are being recruited from a major rehabilitation center serving both urban and rural populations, which may improve the representativeness of the sample within the regional context. Additionally, the focus on self-identified goals using client-centered tools enhances the applicability across diverse needs of individuals with chronic stroke.

However, some limitations must be acknowledged. The sample size is modest, which may reduce power to detect small between-group differences, and long-term follow-up beyond 1 month is not included, limiting understanding of sustained effects. The findings will be intended to provide preliminary insights into the comparative effectiveness of MI and CO-OP, offering a basis for future multi-site studies with longer samples and extended follow-up periods.

Key findings

• This protocol outlines a rigorous methodology to compare the effectiveness of CO-OP and MI in stroke rehabilitation.

• The study will inform future trials and potentially guide clinical decision-making in rehabilitation settings.