StrokeNCT06717776
Effects of Compensation-Based Problem Solving Therapy
A study testing Compensation Based Problem Solving Therapy and standard rehabilitation in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on occupational performance, participation, self-efficacy, and quality of life in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- What is being tested?
- Compensation Based Problem Solving Therapy and standard rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age Stroke time between 3-12 months Scoring 24 and above on the Standardized Mini Mental Test Scoring 16 and below on the NIH Stroke Scale Receiving service in the inpatient service at Etlik City Hospital
Who cannot join
- Having any psychiatric or neurological disease that may affect the study Individuals whose affected hand is not their dominant hand Individuals who tend to neglect their affected hand
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06800
About this study
Official title: Effects of Compensation-Based Problem-Solving Therapy on Occupational Performance, Self Efficacy, Participation and Quality of Life After Stroke: A Randomized Controlled Trial
The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on occupational performance, participation, self-efficacy, and quality of life in individuals with stroke.
Read the detailed description
The study was designed as a randomized controlled trial. A simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). A simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. Following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. This decision determined whether the individual would be included in the intervention or control group. The study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of Etlik City Hospital. The study was approved by the Ethics Committee of Etlik City Hospital on May 17, 2023, and was assigned the code AEŞH-EK1-2023-176. Following approval from the ethics committee, the Compensation-Based Problem Solving Training (CBPST) was developed. The training program was developed in accordance with the tenets of the Occupational Adaptation Model. All subsequent steps were conducted in accordance with the aforementioned model. The adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. The therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. Subsequently, the final iteration of the training program was established. All individuals included in the study signed a consent form indicating their willingness to participate. This was completed at the outset of the study. All individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. In addition to this, the intervention group received CBPST in the form of five days a week (20 minutes) sessions. The evaluations completed at the beginning of the training were repeated one month later.
- Conditions
- Stroke
- Being tested
- Compensation Based Problem Solving Therapy, standard rehabilitation
- Keywords
- stroke, compensation, self-efficacy, problem solving, participation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensation Based Problem Solving TherapyBehavioural
Compensation-Based Problem Solving Therapy (CB-PST) is a therapeutic approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in daily life activities. The therapy encompasses the implementation of problem-solving training.
The occupational problem is defined.
The development of compensation-focused strategies is based on the "personal factors" and "occupational environment" identified as relevant to the problematic occupation, as determined according to the principles of the occupational adaptation model.
Once a compensatory strategy has been selected, the next step is to apply it and evaluate its efficacy, with the expectation that an "adaptive response" will be observed, and that the resulting adaptation will be reflected in improved occupational performance, as guided by the occupational adaptation model.
standard rehabilitationBehavioural
The standard rehabilitation program is provided to all individuals in the inpatient service on an equal basis. The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. These units are staffed by physiotherapists and occupational therapists. All individuals included in the study received the same service from the same therapists at the same times in a homogeneous manner. All individuals received physiotherapy, electrotherapy, and hydrotherapy as part of this service. In the physiotherapy unit, the first intervention was 25 minutes of electrotherapy for the upper extremity. This was followed by 40 minutes of physiotherapy exercises, conducted with the assistance of a physiotherapist. The final component of the physiotherapy unit programme was 15 minutes of hydrotherapy. In the occupational therapy unit, a standard 40-minute occupa
| Study group | Role | What they receive |
|---|---|---|
| Aspirin (intervention group) | Active comparator | The intervention group received both compensation-bocused problem-solving therapy and standard rehabilitation services.
Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays.
Compensation Based Problem Solving Therapy (CFPS) is an approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in activities of daily living. Receives: Behavioral: Compensation Based Problem Solving Therapy; Behavioral: standard rehabilitation |
| Plasebo (control group) | Active comparator | The control group received standard rehabilitation services.
Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. Receives: Behavioral: standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a measurement tool that is specific to the individual and is used to evaluate the performance and satisfaction of individuals in their activities of daily living. The COPM employs a person-centered approach, encompasses a comprehensive scope, and assesses performance and satisfaction. The tool includes the following components: problem definition, prioritization, scoring, goal setting, and re-evaluation. The COPM comprises three domains of occupational performance: self-care, work and productive activities, and leisure time activities. The individual's desired occupations within these areas are identified and assigned a score between 1 and 10. Subsequently, the five most significant occupations are identified from the aforementioned list and performance and satisfaction scores are assigned a value between 1 and 10. The total performance and total satisfaction levels of these occupations are then recorded. Additionally, the total
Measured: 1 month
Secondary outcomes (3)
The Stroke Specific Quality of Life Scale (SSQLS)
The Stroke Specific Quality of Life Scale (SSQLS) is a measurement tool developed for the purpose of evaluating the quality of life of individuals who have experienced a stroke. This scale is employed to ascertain the impact of stroke on the physical, emotional, and social well-being of the individual, thereby informing the formulation of treatment and intervention plans that align with these effects. The scale has the advantages of being a stroke-specific tool, comprehensive, and sensitive to the patient. The scale comprises 12 domains and 49 items. The aforementioned areas encompass the following domains: energy, family roles, movement, emotions, personal care, social roles, communication, vision, thinking, upper extremity functions, pain, work and productivity. The item numbers in these areas vary. However, each area is scored using a Likert-type scale, with scores ranging from 1 (indicating a high level of dissatisfaction) to 5 (indicating a high level of satisfaction). Subsequent
Measured: 1 month
Daily Living Self Efficacy Scale
It is a tool used to evaluate one's own efficacy in everyday activities. This scale assesses an individual's capacity to fulfill specific roles and responsibilities, providing an insight into their intrinsic capability. The concept of self-efficacy is comprised of two sub-categories: social and everyday. The psychosocial sub-category encompasses eight items, while the activies of daily living sub-category encompasses four items, for a total of 12 items. A rating system is in use, with a scale of 0 to 100. A higher score is indicative of a higher level of self-efficacy.
Measured: 1 month
Participation Scale
It is a measurement tool utilized to assess the extent of individual participation in social activities and the constraints they encounter in this participation. The scale was developed with the specific purpose of measuring social isolation and understanding the capacity of individuals to fulfill their roles in society. The P-Scale is typically employed to assess the level of participation of individuals coping with chronic illnesses, physical disabilities, mental health concerns, or social disadvantages within society. The scale comprises 18 items, with responses scored on a Likert scale from 1 (no problems) to 5 (severe participation restrictions). A high score indicates a significant limitation in the individual's capacity to engage in social activities. The scale offers several advantages, including cultural flexibility, straightforward administration, individualized assessment, and sensitivity to the specific circumstances of the individual being evaluated.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion1 Jul 2025
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with an intervention group and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya Ozturk, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717776
- Sponsor's protocol ID
- HÜ-OT-LKO-01
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2024
- Last updated
- 9 Feb 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compensation-Based Problem-Solving Therapy on Occupational Performance, Self Efficacy, Participation and Quality of Life After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06717776
- Acronym / sponsor ID
- HÜ-OT-LKO-01
- Conditions
- Stroke
- Keywords
- stroke, compensation, self-efficacy, problem solving, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 5 Dec 2024 (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 aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on occupational performance, participation, self-efficacy, and quality of life in individuals with stroke.
Detailed description
The study was designed as a randomized controlled trial. A simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). A simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. Following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. This decision determined whether the individual would be included in the intervention or control group. The study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of Etlik City Hospital. The study was approved by the Ethics Committee of Etlik City Hospital on May 17, 2023, and was assigned the code AEŞH-EK1-2023-176. Following approval from the ethics committee, the Compensation-Based Problem Solving Training (CBPST) was developed. The training program was developed in accordance with the tenets of the Occupational Adaptation Model. All subsequent steps were conducted in accordance with the aforementioned model. The adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. The therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. Subsequently, the final iteration of the training program was established. All individuals included in the study signed a consent form indicating their willingness to participate. This was completed at the outset of the study. All individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. In addition to this, the intervention group received CBPST in the form of five days a week (20 minutes) sessions. The evaluations completed at the beginning of the training were repeated one month later.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with an intervention group and a control group
| Arm | Type | Receives |
|---|---|---|
| Aspirin (intervention group) | Active comparator | Behavioral: Compensation Based Problem Solving Therapy, Behavioral: standard rehabilitationThe intervention group received both compensation-bocused problem-solving therapy and standard rehabilitation services. Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. Compensation Based Problem Solving Therapy (CFPS) is an approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in activities of daily living. |
| Plasebo (control group) | Active comparator | Behavioral: standard rehabilitationThe control group received standard rehabilitation services. Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age Stroke time between 3-12 months Scoring 24 and above on the Standardized Mini Mental Test Scoring 16 and below on the NIH Stroke Scale Receiving service in the inpatient service at Etlik City Hospital
Key exclusion criteria (1 listed)
- Having any psychiatric or neurological disease that may affect the study Individuals whose affected hand is not their dominant hand Individuals who tend to neglect their affected hand
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 |
|---|---|---|
| Compensation Based Problem Solving TherapyCompensation-Based Problem Solving Therapy (CB-PST) is a therapeutic approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in daily life activities. The therapy encompasses the implementation of problem-solving training. The occupational problem is defined. The development of compensation-focused strategies is based on the "personal factors" and "occupational environment" identified as relevant to the problematic occupation, as determined according to the principles of the occupational adaptation model. Once a compensatory strategy has been selected, the next step is to apply it and evaluate its efficacy, with the expectation that an "adaptive response" will be observed, and that the resulting adaptation will be reflected in improved occupational performance, as guided by the occupational adaptation model. | Behavioural | Aspirin (intervention group) |
| standard rehabilitationThe standard rehabilitation program is provided to all individuals in the inpatient service on an equal basis. The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. These units are staffed by physiotherapists and occupational therapists. All individuals included in the study received the same service from the same therapists at the same times in a homogeneous manner. All individuals received physiotherapy, electrotherapy, and hydrotherapy as part of this service. In the physiotherapy unit, the first intervention was 25 minutes of electrotherapy for the upper extremity. This was followed by 40 minutes of physiotherapy exercises, conducted with the assistance of a physiotherapist. The final component of the physiotherapy unit programme was 15 minutes of hydrotherapy. In the occupational therapy unit, a standard 40-minute occupa | Behavioural | Aspirin (intervention group), Plasebo (control group) |
Primary outcome
The Canadian Occupational Performance Measure (COPM)
Time frame: 1 month
The Canadian Occupational Performance Measure (COPM) is a measurement tool that is specific to the individual and is used to evaluate the performance and satisfaction of individuals in their activities of daily living. The COPM employs a person-centered approach, encompasses a comprehensive scope, and assesses performance and satisfaction. The tool includes the following components: problem definition, prioritization, scoring, goal setting, and re-evaluation. The COPM comprises three domains of occupational performance: self-care, work and productive activities, and leisure time activities. The individual's desired occupations within these areas are identified and assigned a score between 1 and 10. Subsequently, the five most significant occupations are identified from the aforementioned list and performance and satisfaction scores are assigned a value between 1 and 10. The total performance and total satisfaction levels of these occupations are then recorded. Additionally, the total
3 secondary outcomes
The Stroke Specific Quality of Life Scale (SSQLS)
Time frame: 1 month
Daily Living Self Efficacy Scale
Time frame: 1 month
Participation Scale
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- The effectiveness of problem solving therapy for stroke patients: study protocol for a pragmatic randomized controlled trialLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensation Based Problem Solving Therapy and standard rehabilitation in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Canadian Occupational Performance Measure (COPM) (time frame: 1 month). 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 9 Feb 2026.