Clinical trial NCT06717776: Development of Compensation-Based Problem Solving Therapy
Official title: Development of Compensation-Based Problem Solving Therapy (CBPST) and Investigation of Its Effects on Individuals With Stroke : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: stroke
activities of daily living
compensation
self-efficacy
problem solving
participation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with an intervention group and a control group
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on activities of daily living, 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: 1 month
Secondary outcomes:
measure: The Stroke Specific Quality of Life Scale (SSQLS)
timeFrame: 1 month
measure: Daily Living Self Efficacy Scale
timeFrame: 1 month
measure: Participation Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
state: Yenimahalle
Study officials:
References: