An interventional study of Occupational Performance Coaching (OPC) and computer cognitive training program (CogniFit) in Stroke, sponsored by Queen's University. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Queen's University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine whether Occupational Performance Coaching (OPC), a person-centered, strength-based intervention, can improve participation in valued activities among adults who have experienced a stroke and recently completed community- or clinic-based stroke rehabilitation.
The main questions it aims to answer are:
Does OPC improve performance and satisfaction with participation in personally valued activities?
Does OPC improve participation self-efficacy, physical activity, cognition, and emotional well-being compared to an active attention control intervention?
Researchers will compare the OPC group to an active attention control group to see if OPC leads to greater improvements in participation and secondary outcomes.
Participants will:
Be randomized to receive either OPC (delivered virtually, including collaborative goal-setting and problem-solving) or an active attention control intervention.
Complete assessments of participation in valued activties, physical activity (using movement sensors), self-efficacy, cognition, and mood immediately after treatment and at 3 months.
A subset of 20 participants from intervention group will take part in interviews to share their experiences.
Most stroke survivors, access of all levels of impairment, have difficulty returning to valued activities and social roles, leading to loss of sense of self and purpose in life and impacting both physical and mental health. Occupational Performance Coaching (OPC) shows promise in quickly returning people to their valued activities, thereby offering hope and improving well-being. This project asks, "Will OPC, an innovative adaptive approach to returning people quickly to their valued activities, lead to increased participation for individuals with stroke?"
The experience of stroke is devastating for both stroke survivors and their families. The process of picking up the pieces, adjusting, and finding ways to engage in activities that provide meaning and purpose is complex, requiring emotional and practical support, access to information, and opportunities to test abilities and try new ways of doing. With much of the focus of rehabilitation practice and guidelines being on reducing impairment, it is not surprising that stroke survivors feel lost and ill-prepared to participate in their valued activities when formal rehabilitation ends. Effective adaptive interventions are needed to return people quickly to activities to prevent negative outcomes associated with decreased participation.
OPC is a person-centred, strengths-based, adaptive approach that focuses on providing emotional support, collaborative goal setting, solution-focused problem-solving, and experimentation to build knowledge, skills, and self-efficacy for participation. OPC capitalizes on modifiable factors influencing participation after stroke. and builds the skills needed for stroke survivors to continue setting and achieving goals on their own.
OPC is the most widely researched coaching intervention in occupational therapy and stroke rehabilitation. PI Kessler the lead international researcher testing OPC with adults with neurological conditions, namely stroke and multiple sclerosis. Pilot feasibility studies demonstrated the potential of OPC, delivered in person or virtually, to return individuals living with stroke to valued activities within 8-10 sessions.
Based on previous participation research, through enhancing participation in personally valued activities, OPC may enhance self-efficacy, physical activity, cognitive abilities, and emotional well-being.
The proposed study will establish the efficacy of OPC for improving participation in valued activities (Canadian Occupational Performance Measure), self-efficacy (Participation Strategeis Self-Efficacy Scale), physical activity (AcivPal activity monitor), cognition (CogniFit computerized assessments : a)Trail Making Test measures processing speed, shifting and visual attention; b) the Stroop test measures inhibition, updating, visual perception, naming, processing speed and response time; and c) the Visual Working Memory Span Test measures spatial perception, short-term memory, visual short-term memory, non-verbal memory, working memory, planning, processing speed, and response time), and emotional well-being (Generalized Anxiety Disorders Scale-7 and Brief Patient Health Questionnaire ). In addition, wthe investigators will conduct a process evaluation to examine characteristics of participants that act as mediators or moderators to improve participation in valued activity goals and to explore how OPC works with different subgroups of stroke participants (e.g., stroke severity, age, sex, and gender).
The investigators will conduct a double-blind randomized controlled trial to test whether OPC delivered virtually enhances participation in valued activities among people with stroke compared to an active control condition.
The investigators will recruit 118 patients from inpatient stroke rehabilitation and randomly assign them (stratified by stroke severity) to OPC (intervention group) or computerized cognitive therapy with check-ins (active control group) at the end of publicly funded rehabilitation. Participants will be 3 to 12 months post-stroke. A blinded research assistant will administer outcomes at baseline, post-intervention, and at 3-month follow-up. The primary outcome will be participation in valued activities. Secondary outcomes will be participation self-efficacy, physical activity, cognition, and emotional well-being. The investigators will examine mediators and moderators that impact the outcome of OPC and interview a subsample of 20 participants who receive OPC to better understand how OPC works with people of different stroke severity, age, sex, and gender.
Participants, blinded to study purposes, will receive 10 one-hour sessions of either OPC or an active control delivered virtually using Zoom over 15 weeks.
Between-group differences across the three timepoints for each outcome will be tested using repeated measures ANOVA. Interview transcripts will be analyzed using content analysis.
This project addresses an important knowledge gap related to improving participation among patients with stroke. The investigators will establish the efficacy of OPC, an established adaptive intervention, and expand our understanding of how it works. Without evidence-based interventions to promote participation, stroke survivors will continue to struggle to return to valued activities and miss out on associated health benefits (physical, cognitive, emotional). This work will also build on evidence for virtual approaches to stroke rehabilitation; these approaches have the potential to improve accessibility to rehabilitation for stroke survivors.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 118 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
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Exclusion Criteria:
Participants will receive 10 one-hour telerehabilitation sessions delivered via Zoom (Zoom Video Communications Inc., San Jose, CA) over a 15-week period. Sessions will be delivered by an Occupational Therapist trained in the Occupational Performance Coaching (OPC) approach and in telerehabilitation service delivery. The 15-week period allows flexibility for scheduling (e.g., to accommodate appointments or vacations).
Behavioral: Occupational Performance Coaching (OPC)
Participants will receive access to the CogniFit (computer cognitive training program (CogniFit Inc. © 2024) for 15 weeks. There will be 10 virtual contacts via Zoom. The AC interventionist will be trained in telerehabilitation service delivery. The program is designed to train perception, attention, memory, and reasoning.
Device: computer cognitive training program (CogniFit)
Occupational Performance Coaching (OPC) is an innovative, person-centered, strengths-based intervention designed to enhance participation in valued activities after stroke. OPC targets modifiable factors such as goal setting, self-efficacy, emotional support, problem-solving, and individualized education. Through a collaborative process, therapists partner with stroke survivors to identify challenges, set meaningful goals, and experiment with tailored solutions, refining them until successful strategies are found. Research shows OPC is feasible, acceptable, and effective, with participants demonstrating significant improvements in performance, satisfaction, and re-engagement in valued activities within 8-10 sessions, both in-person and via telerehabilitation. By fostering physical, cognitive, and emotional well-being, OPC addresses barriers like social isolation, physical inactivity, and low self-efficacy. Delivered virtually, OPC overcomes challenges in accessing rehabilitation, parti
Active control (AC) group will receive access to the CogniFit computer-based cognitive training program, a personalized brain training tool designed to target perception, attention, memory, and reasoning.While cognitive training can improve global cognition, working memory, attention, and executive function, it has not shown effects on daily activities or depression.
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a reliable, valid, and responsive tool frequently used in stroke rehabilitation outcome studies. Using the COPM, participants identify problems related to participation in valued activities that are then rated by participants for performance and satisfaction with current status on a scale of 1-10, where 10 indicates optimal performance or satisfaction. Numbers are summed and divided by the number of goals.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Participation Strategies Self-Efficacy Scale (PS-SES)
The Participation Strategies Self-Efficacy Scale (PS-SES) is a 35-item scale that measures self-efficacy in using strategies for participation in home, community, work, and social activities. Each item is scored on a scale of 1 (not at all confident) to 10 (totally confident) total score ranges from 35 to 350 with higher scores indicating higher self-efficacy.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Time spent in active veruss sedentary activity
Time spent in active (i.e., standing, walking) versus sedentary (i.e., sitting, lying) activites willk be measured using the ActivPal 4 activity monitor (PAL Technologies Ltd., Glasgow, UK). The ActivPal is a small, lightweight wearable device that measures movement with a triaxial accelerometer and body posture with a gyroscope. Consistent with recommendations for obtaining a good representation of typical physical activity, it will be worn for seven consecutive days ateach data colleciton timepoint. An average of active versus sedentary time will be calculated.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Generalized Anxiety Disorders Scale-7 (GAD-7)
The Generalized Anxiety Disorders Scale-7 (GAD-7) is a brief 7-item screening tool for anxiety that captures the frequency of anxiety-related symptoms. The GAD-7 is a valid, reliable, and responsive measure commonly used in stroke rehabilitation research. Items are socred on a scale of 0 (not at all) to 3 (nearly everyday). Total score ranges from 0-21 with higher scores indicating higher anxiety.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Executive Functioning
Executive functioning will be measured using the following CogniFit computerized assessments : a) the Trail Making Test (TMT) measures processing speed, shifting and visual attention; b) the Stroop test measures inhibition, updating, visual perception, naming, processing speed and response time; and c) the Visual Working Memory Span Test measures spatial perception, short-term memory, visual short-term memory, non-verbal memory, working memory, planning, processing speed, and response time. These tests have demonstrated reliability and validity with older adults. Overall executive functioning will be represented using Z scores.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Brief Patient Health Questionnaire (PhQ-9)
The Brief Patient Health Questionnaire (PHQ-9) is a brief 9-item screening tool for depression. PhQ-9 is a valid, reliable, and responsive measure commonly used in stroke rehabilitation research. Items are scored on a scale of 0 (not at all) to 3 (nearly every day). Total score ranges form 0 to 27 with higher scores indicating higher depression.
Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment
Plan to share: Yes — Anonymized data will be deopsited in the Queen's University research data repository
Supporting information: Study protocol
Time frame: IPD wil be shared following study completion
Access criteria: Ethics approval will be required to addess the data that is available through the Queen's University repository
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