- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06717776
Effects of Compensation-Based Problem Solving Therapy
Effects of Compensation-Based Problem-Solving Therapy on Occupational Performance, Self Efficacy, Participation and Quality of Life After Stroke: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06800
- Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Aspirin (intervention group)
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. |
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.
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
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Active Comparator: Plasebo (control group)
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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Stroke Specific Quality of Life Scale (SSQLS)
Time Frame: 1 month
|
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
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1 month
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Daily Living Self Efficacy Scale
Time Frame: 1 month
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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.
|
1 month
|
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Participation Scale
Time Frame: 1 month
|
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.
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HÜ-OT-LKO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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